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Kpe 220 Ts, Nonsterile

by Ipax, Inc.

510(k) K914221

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 · Traditional NumberK914221 Date25 Oct 1991ClearedStatusActive

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  • Withdrawn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
HQE
Device Class
Class II
Regulation
21 CFR Part 886.4150
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Kpe 220 Ts, Nonsterile is an AC-powered instrument used for vitreous aspiration and cutting. It is classified as an ophthalmic device under regulation number 886.4150.

This device is supplied in a nonsterile state. It is subject to FDA 510(k) authorization under K914221.

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Questions

AI-generated answers, 21 Sep 2026

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

  • What is the primary function of the KPE 220 TS?

    The KPE 220 TS is an AC-powered medical instrument specifically designed for vitreous aspiration and cutting procedures within ophthalmic surgery.

  • How is the KPE 220 TS supplied to the clinician?

    This device is supplied in a nonsterile state. Clinicians must ensure appropriate sterilization protocols are followed prior to use in a clinical setting.

  • What is the regulatory status of this device?

    The KPE 220 TS has received FDA 510(k) authorization under submission number K914221. It is classified as an ophthalmic device under regulation number 886.4150.