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Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso

by Nonin Medical, Inc.

510(k) K160865

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160865↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK160865 Date5 Aug 2016ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DQA
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

These devices are single-use or reusable pulse oximeter sensors designed to measure oxygen saturation (SpO₂) and pulse rate non-invasively. The disposable series (Models 6100C, 6101C, and 6102C) are intended for one-time patient use, while the reusable models (8100AA/8100AP and 8101AA/8101AP) feature a finger clip design for repeated clinical applications.

The disposable sensors are supplied sterile and intended for single-patient use, ensuring infection control. The reusable sensors are designed for durable clinical environments and require cleaning and sterilisation between uses. All models comply with FDA 510(k) clearance and MDD directives, with the disposable series classified under product code DQA. Sizes and configurations vary by model, with the disposable series available in multiple variants (e.g., CA, CP, CI, CN) for different patient applications.

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these pulse oximeter sensors designed for single-use or can they be reused, and how does that affect their use in clinical settings?

    The 6100C, 6101C, and 6102C series are single-use, disposable sensors, supplied sterile and intended for one-time patient use to ensure infection control. In contrast, the 8100AA/8100AP and 8101AA/8101AP models are reusable finger clip sensors, designed for repeated clinical applications with required cleaning and sterilization between uses. This distinction helps facilities balance convenience (disposable) with cost efficiency (reusable) based on their workflow and infection control protocols.

  • What types of configurations or sizes are available for the disposable pulse oximeter sensors, and how might they differ in clinical use?

    The disposable sensors (6100C, 6101C, and 6102C series) come in multiple variants—CA, CP, CI, and CN—which likely cater to different patient applications, such as varying finger sizes, pediatric use, or specific clinical needs like neonatal monitoring. While the exact differences aren’t detailed here, the variety ensures compatibility with diverse patient populations and procedural requirements, such as surgery, ICU care, or outpatient settings.

  • How should the reusable sensors be maintained between uses, and what cleaning or sterilization methods are recommended?

    The reusable sensors (8100AA/8100AP and 8101AA/8101AP) are designed for durable clinical use but require cleaning and sterilization between patients to prevent cross-contamination. While the data doesn’t specify exact protocols, standard practices for reusable medical devices—such as autoclaving, chemical sterilization, or manufacturer-recommended cleaning agents—would apply. Always follow the manufacturer’s instructions to ensure safety and longevity of the sensors.

  • What regulatory pathways have these pulse oximeter sensors undergone, and how does that impact their use in healthcare facilities?

    These devices have undergone FDA 510(k) clearance and comply with MDD (Medical Device Directive) directives, confirming they meet U.S. and European regulatory standards for safety and performance. The disposable series is classified under product code DQA, which categorizes them as diagnostic, non-invasive devices for measuring oxygen saturation (SpO₂) and pulse rate. This regulatory clearance ensures they can be legally marketed and used in clinical settings where pulse oximetry is required, such as hospitals, surgical centers, or home healthcare.