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DeVilbiss 3655PL-IH

by DeVilbiss Healthcare LLC.

DeVilbiss 3655PL-IH is a Class II device made by DeVilbiss Healthcare LLC., cleared under FDA 510(k) K020932 on 28 Jun 2002 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00885304001492), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K020932

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 Number00885304001492 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020932 Date28 Jun 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020932 decided 28 Jun 2002 Active
  • FDA GUDID UDI-DI 00885304001492 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020932
  2. Listed FDA GUDID 00885304001492

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DeVilbiss
Generic name
Medical device air compressor
Model / Ref / Catalog
3655PL-IH
Primary DI / UDI-DI
00885304001492
510(k) Number
FDA product code
CAF, BTI
GMDN term
Medical device air compressor
Device class
Class II
Regulation number
868.5630, 868.6250
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K020932)

Similar devices

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)