Fertility Awareness Method Kit

by Telesis Corp.

510(k) K801791

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

510(k) K801791↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK801791	Date31 Oct 1980Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K801791
FDA Product Code: FLK

Device Class: Class II
Regulation: 21 CFR Part 880.2920
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Fertility Awareness Method Kit is a clinical mercury thermometer device used for tracking basal body temperature as part of fertility awareness-based methods. It is classified as a Class II medical device under FDA regulation 880.2920 with product code FLK.

The device was cleared via the traditional 510(k) pathway under submission K801791, with a decision date of October 31, 1980, and is manufactured by Telesis Corp. in Walker, Michigan. It is intended for general hospital use and has no indicated sterility, single-use, or MRI safety specifications in the provided data.