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Precept® 15116

by Precept Medical Products, Inc.

Precept® 15116 is a Class II device made by Precept Medical Products, Inc., cleared under FDA 510(k) K934969 on 28 Mar 1994 and listed in FDA GUDID since 31 Jan 2018 (UDI-DI 10814707021490), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K934969

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10814707021490 UDI-DI Date31 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK934969 Date28 Mar 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K934969 decided 28 Mar 1994 Active
  • FDA GUDID UDI-DI 10814707021490 listed 31 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K934969
  2. Listed FDA GUDID 10814707021490

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Precept®
Generic name
Surgical/medical face mask, single-use
Model / reference
15116
Primary DI / UDI-DI
10814707021490
510(k) Number
FDA product code
FXX
GMDN term
Surgical/medical face mask, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical face mask, single-use

Cleared under the same submission (K934969)

and 8 more cleared under K934969

Similar devices

Other devices filed under FDA product code FXX (Mask, Surgical).

Other devices from Precept Medical Products, Inc.

See all devices from Precept Medical Products, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)