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Medline HCS93500

by Medline Industries, Inc.

Medline HCS93500 is an incentive spirometer (FDA Class II; FDA product code BWF, Spirometer, Therapeutic (Incentive)) made by Medline Industries, Inc., cleared under FDA 510(k) K141355 on 3 Sep 2014 and listed in FDA GUDID since 10 Jun 2022 (UDI-DI 10888277409156), 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) K141355

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 Number10888277409156 UDI-DI Date10 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK141355 Date3 Sep 2014IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141355 decided 3 Sep 2014 Active
  • FDA GUDID UDI-DI 10888277409156 listed 10 Jun 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141355
  2. Listed FDA GUDID 10888277409156

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medline
Generic name
Incentive spirometer
Model / Ref / Catalog
HCS93500
Primary DI / UDI-DI
10888277409156
510(k) Number
FDA product code
BWF
GMDN term
Incentive spirometer
Device class
Class II
Regulation number
868.5690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Incentive spirometer

Cleared under the same submission (K141355)

and 2 more cleared under K141355

Similar devices

Other devices filed under FDA product code BWF (SPIROMETER, THERAPEUTIC (INCENTIVE)).

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →

Properties

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