3M Comply Hydrogen Peroxide Indicator Tape 1228
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K150694 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 3M Comply Hydrogen Peroxide Indicator Tape 1228 is a chemical indicator used to monitor vaporized hydrogen peroxide (VHP) sterilization cycles. It consists of a non‑cellulosic plastic backing with a pressure‑sensitive adhesive on one side and indicator stripes on the other that change from blue to pink when exposed to VHP. The tape is applied to non‑woven disposable wraps and peel pouches to provide a visual confirmation that the sterilization process has been achieved.
The indicator tape is classified as a Class 2 device (product code JOJ) and has received FDA 510(k) clearance (decision description: Substantially Equivalent). It is supplied as a disposable tape (model 1228) for use with STERRAD® sterilization systems (Models 50, 100S and 100). The device is regulated under 21 CFR 880.2800 and is intended for single‑use application in hospital sterilization settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 3M Comply Hydrogen Peroxide Indicator Tape 1228 3M Comply Hydrogen ..., 3M™ Comply™ Hydrogen Peroxide Indicator Tape, 1228, PDF 3M Comply Hydrogen Peroxide Indicator Tape1228, 3M Chemical Indicator Tapes for Medical | 3M United States
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150694 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K150694 24 fields · synced Sep 25, 2026