# Burke, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Burke, Inc. is a medical device manufacturer, with 47 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/burke-inc>
- Country: United States (FDA applicant, unverified)
- Role: Manufacturer
- DUNS: 045093101

## Figures

- Devices: 47
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 40, FDA 510(k) 7
- Device classes: FDA Class II 45, FDA Class I 2

## Devices

The first 47 of 47, in the order of the canonical page, which lists them all.

- [Pacesaver Plus III Premier](https://devicerts.com/devices/pacesaver-15067) · Class II · GUDID · status: Active
- [Scout M-1 350](https://devicerts.com/devices/scout-81855a) · Class II · GUDID · status: Active
- [Pacesaver Plus III Atlas](https://devicerts.com/devices/pacesaver-15083) · Class II · GUDID · status: Active
- [PaceSaver Fusion 250](https://devicerts.com/devices/pacesaver-17478) · Class II · GUDID · status: Active
- [Scout Boss 4.5 TPB](https://devicerts.com/devices/scout-82389) · Class II · GUDID · status: Active
- [PaceSaver Espree Atlas 5](https://devicerts.com/devices/pacesaver-15086) · Class II · GUDID · status: Active
- [Burke Tri-Flex II](https://devicerts.com/devices/burke-63398b) · Class II · GUDID · status: Listed
- [Pacesaver Plus III Junior](https://devicerts.com/devices/pacesaver-15070) · Class II · GUDID · status: Active
- [Scout RF 4-P](https://devicerts.com/devices/scout-82554) · Class II · GUDID · status: Active
- [Scout M-1 TPB](https://devicerts.com/devices/scout-82338) · Class II · GUDID · status: Active
- [Scout RF-P4 TPB-N](https://devicerts.com/devices/scout-82647) · Class II · GUDID · status: Listed
- [Pacesave Fusion 500](https://devicerts.com/devices/pacesave-15090) · Class II · GUDID · status: Active
- [Scout Boss 6 TPB](https://devicerts.com/devices/scout-82676) · Class II · GUDID · status: Active
- [Scout TPB](https://devicerts.com/devices/scout-83182) · Class II · GUDID · status: Listed
- [Scout Boss 4.5 N/S](https://devicerts.com/devices/scout-82348) · Class II · GUDID · status: Active
- [Pacesaver Espree Titan](https://devicerts.com/devices/pacesaver-15057) · Class II · GUDID · status: Active
- [Pacesaver Espree' Premier](https://devicerts.com/devices/pacesaver-15068) · Class II · GUDID · status: Active
- [Scout RF-P4](https://devicerts.com/devices/scout-82491) · Class II · GUDID · status: Active
- [Scout RF-P4 W/S](https://devicerts.com/devices/scout-83173) · Class II · GUDID · status: Active
- [Burke Bari-Float Mattress 54"](https://devicerts.com/devices/burke-63410) · Class I · GUDID · status: Listed
- [Scout RF4](https://devicerts.com/devices/scout-81122) · Class II · GUDID · status: Active
- [Pacesaver Fusion 450](https://devicerts.com/devices/pacesaver-15085) · Class II · GUDID · status: Active
- [Burke Bari-Float Mattress 48"](https://devicerts.com/devices/burke-63187) · Class I · GUDID · status: Listed
- [Scout Boss 6](https://devicerts.com/devices/scout-82628) · Class II · GUDID · status: Active
- [Scout Boss 6NS TPB](https://devicerts.com/devices/scout-82306) · Class II · GUDID · status: Listed
- [Scout 4 P](https://devicerts.com/devices/scout-83181) · Class II · GUDID · status: Active
- [Pacesaver Espree Atlas](https://devicerts.com/devices/pacesaver-15035) · Class II · GUDID · status: Active
- [Scout RF - SP](https://devicerts.com/devices/scout-81113a) · Class II · GUDID · status: Active
- [Scout Boss 6.75 TPB](https://devicerts.com/devices/scout-82677) · Class II · GUDID · status: Active
- [Pacesaver Eclipse Atlas 5](https://devicerts.com/devices/pacesaver-15087) · Class II · GUDID · status: Active
- [Scout Boss 6.75](https://devicerts.com/devices/scout-82062) · Class II · GUDID · status: Active
- [Pacesaver Eclipse Atlas](https://devicerts.com/devices/pacesaver-15073) · Class II · GUDID · status: Active
- [Pacesaver Eclipse Premier](https://devicerts.com/devices/pacesaver-15072) · Class II · GUDID · status: Active
- [Scout RF-P4 TPB-S](https://devicerts.com/devices/scout-83180) · Class II · GUDID · status: Active
- [Burke Inc Tri-Flex Air](https://devicerts.com/devices/burke-inc-63390) · Class II · GUDID · status: Listed
- [Scout Boss 6NS](https://devicerts.com/devices/scout-82250) · Class II · GUDID · status: Active
- [Pacesaver Fusion 350](https://devicerts.com/devices/pacesaver-17477) · Class II · GUDID · status: Active
- [Pacesaver Plus III Titan](https://devicerts.com/devices/pacesaver-15063) · Class II · GUDID · status: Active
- [Scout M-1](https://devicerts.com/devices/scout-81445a) · Class II · GUDID · status: Active
- [PS Scout RF TPB](https://devicerts.com/devices/ps-scout-82565) · Class II · GUDID · status: Active
- [Fusion](https://devicerts.com/devices/fusion-ini) · ref K061912 · Class II · 510(k) · status: Active · decision 2006-08-01
- [Pacesaver & Scout](https://devicerts.com/devices/pacesaver-and-scout-ini) · ref K834506 · Class II · 510(k) · status: Active · decision 1984-01-30
- [Concept Model 5200 Thermal Therapy System](https://devicerts.com/devices/concept-model-5200-thermal-therapy-system-ilo) · ref K911943 · Class II · 510(k) · status: Active · decision 1991-07-19
- [Scout Boss](https://devicerts.com/devices/scout-boss-iti) · ref K023961 · Class II · 510(k) · status: Active · decision 2002-12-24
- [Pace Saver, Little Junior (Modification)(Motorized Three-Wheeled Vehicle)](https://devicerts.com/devices/pace-saver-little-junior-modification-motorized-three-wheele-ini) · ref K965123 · Class II · 510(k) · status: Active · decision 1997-07-17
- [Scout](https://devicerts.com/devices/scout-iti) · ref K982158 · Class II · 510(k) · status: Active · decision 1998-08-31
- [Cold/Hot Fluid Radiation Pad Neutech](https://devicerts.com/devices/cold-hot-fluid-radiation-pad-neutech-ilo) · ref K893706 · Class II · 510(k) · status: Active · decision 1989-06-22

## Source and citation

- Cite as: Burke, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/burke-inc (data as of 2026-11-15).
- Data sources: [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/burke-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/burke-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.