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Iontopatch

by Birch Point Medical, Inc.

510(k) K992708

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992708 Date1 Feb 2000ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2197-2025 FDA Class II initiated 22 May 2025
    • Ongoing Z-2196-2025 FDA Class II initiated 22 May 2025

    The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

    • Terminated Z-0454-2022 FDA Class III initiated 10 Nov 2021

    The dosage information on the pouch is incorrect; the primary carton label is correct.

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  • Withdrawn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
EGJ
Device Class
Class II
Regulation
21 CFR Part 890.5525
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent