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ProKids FM85030

by Prestige Ameritech

ProKids FM85030 is a Class II device made by Prestige Ameritech, cleared under FDA 510(k) K160100 on 7 Oct 2016 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00852212003214), active as of 22 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 22 Oct 2026

Documents

510(k) K160100

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160100 Date7 Oct 2016DecidedStatusActive
United StatesGUDID listing Number00852212003214 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160100 decided 7 Oct 2016 Active
  • FDA GUDID UDI-DI 00852212003214 listed 26 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00852212003214
  2. Cleared FDA 510(k) K160100

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProKids
Generic name
Surgical/medical face mask, non-antimicrobial, single-use
Model / reference
FM85030
Primary DI / UDI-DI
00852212003214
510(k) Number
FDA product code
OXZ
GMDN term
Surgical/medical face mask, non-antimicrobial, 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 (K160100)

Similar devices

Other devices filed under FDA product code OXZ (Pediatric/Child Facemask).

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)