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Disposable Pharmaseal Temperature Monitoring Probe

by American Pharmaseal Div. Ahsc

510(k) K864397

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 NumberK864397 Date1 Dec 1986ClearedStatusActive

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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Disposable Pharmaseal Temperature Monitoring Probe is an electronic clinical thermometer designed for accurate body temperature measurement. Classified under FDA regulation 880.2910, it falls under the category of electronic thermometers intended for general hospital use.

This single-use probe is intended for sterile applications in clinical settings and requires no special storage beyond standard medical device protocols. It was granted FDA 510(k) clearance under K864397 with a decision of Substantially Equivalent (SESE) in 1986, classified as a Class II device under the traditional clearance pathway.

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