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Em Lpeep

by Allied Medical LLC

Em Lpeep is a Class II device made by Allied Medical LLC, cleared under FDA 510(k) K882219 on 30 Aug 1988 and listed in FDA GUDID since 28 May 2024 (UDI-DI 00026072001479), 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) K882219

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 Number00026072001479 UDI-DI Date28 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK882219 Date30 Aug 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K882219 decided 30 Aug 1988 Active
  • FDA GUDID UDI-DI 00026072001479 listed 28 May 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K882219
  2. Listed FDA GUDID 00026072001479

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Em
Generic name
PEEP valve, reusable
Model / reference
LPEEP
Primary DI / UDI-DI
00026072001479
510(k) Number
FDA product code
BYE
GMDN term
PEEP valve, reusable
Device class
Class II
Regulation number
868.5965
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure).

Other devices from Allied Medical LLC

See all devices from Allied Medical LLC →

Properties

  • Lot / batch number
Other properties (14, all answered No)