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Dpm 301-5558

by Engineered Medical Systems, LLC

Dpm 301-5558 is a Class II device made by Engineered Medical Systems, LLC, cleared under FDA 510(k) K003497 on 30 Nov 2000 and listed in FDA GUDID since 12 Dec 2023 (UDI-DI 00841470111199), 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) K003497

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 Number00841470111199 UDI-DI Date12 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK003497 Date30 Nov 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K003497 decided 30 Nov 2000 Active
  • FDA GUDID UDI-DI 00841470111199 listed 12 Dec 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K003497
  2. Listed FDA GUDID 00841470111199

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dpm
Generic name
Airway pressure monitor, non-powered
Model / reference
301-5558
Primary DI / UDI-DI
00841470111199
510(k) Number
FDA product code
CAP
GMDN term
Airway pressure monitor, non-powered
Device class
Class II
Regulation number
868.2600
GUDID distribution status
In Commercial Distribution

Related devices

Category: Airway pressure monitor, non-powered

Cleared under the same submission (K003497)

Other devices from Engineered Medical Systems, LLC

See all devices from Engineered Medical Systems, LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)