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CELERITY HP Indicator Tape

by Steris

510(k) K240760

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Special NumberK240760 Date10 Apr 2024ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JOJ
Device class
Class II
Regulation
21 CFR Part 880.2800
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

The Celerity HP Indicator Tape is a physical/chemical sterilization process indicator classified as an Indicator device. It features a Type 1 process indicator that changes color from pink/magenta to orange, yellow or lighter yellow to provide visual confirmation that a wrapped pack has undergone sterilization.

The tape is supplied for securing synthetic wraps on packs processed with V‑PRO low‑temperature sterilization systems and selected STERRAD models, and each box includes an instructions sheet. It is a single‑use product cleared under FDA 510(k) (special clearance) and is identified by product code JOJ and K‑number K240760.

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