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Bates Blanket

by Joe B. Bates, MD, FAAP

510(k) K894433

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 NumberK894433 Date11 Aug 1989ClearedStatusActive

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  • Withdrawn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
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Bates Blanket is a medical device identified under product code KKX. It is intended for use in general and plastic surgery applications.

This device received FDA 510(k) clearance on August 11, 1989, under reference number K894433. It is manufactured by Joe B. Bates, MD, FAAP, based in Tyler, Texas.

Questions

AI-generated answers, 22 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 intended use of the Bates Blanket?

    The Bates Blanket is indicated for use in general and plastic surgery applications. It is classified under product code KKX, which identifies it as a device intended for surgical environments.

  • What is the regulatory status of this device?

    The Bates Blanket received FDA 510(k) clearance on August 11, 1989, under reference number K894433. This indicates that the device was found to be substantially equivalent to a legally marketed predicate device.

  • Who is the manufacturer of the Bates Blanket?

    The device is manufactured by Joe B. Bates, MD, FAAP, located in Tyler, Texas. The company submitted the device for review under a traditional 510(k) clearance process.