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Frida 100001810

by Fridababy, LLC

Frida 100001810 is a Class II device made by Fridababy, LLC, cleared under FDA 510(k) K212705 on 9 Feb 2022 and listed in FDA GUDID since 12 Sep 2024 (UDI-DI 00810028776166), 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) K212705

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810028776166 UDI-DI Date12 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212705 Date9 Feb 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212705 decided 9 Feb 2022 Active
  • FDA GUDID UDI-DI 00810028776166 listed 12 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212705
  2. Listed FDA GUDID 00810028776166

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Frida
Generic name
Sexual lubricant
Model / reference
100001810
Primary DI / UDI-DI
00810028776166
510(k) Number
FDA product code
PEB
GMDN term
Sexual lubricant
Device class
Class II
Regulation number
884.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sexual lubricant

Similar devices

Other devices filed under FDA product code PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible).

Other devices from Fridababy, LLC

See all devices from Fridababy, LLC →

Properties

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