Unimed SWSD15-16

by Unimed Medical Supplies, Inc.

Unimed SWSD15-16 is a Class II device made by Unimed Medical Supplies, Inc., cleared under FDA 510(k) K142832 on 6 Feb 2015 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 06945664821285), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06945664821285 UDI-DI	Date23 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK142832	Date6 Feb 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 06945664821285
FDA 510(k) database 510(k) number K142832

Across registries

2 registries list this device

FDA 510(k) K142832 decided 6 Feb 2015 Active
FDA GUDID UDI-DI 06945664821285 listed 23 Aug 2016 Listed

Timeline

2 dated events

6 Feb 2015 Cleared FDA 510(k) K142832
23 Aug 2016 Listed FDA GUDID 06945664821285

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Unimed
Generic name: Pulse oximeter probe, reusable
Model / reference: SWSD15-16

Primary DI / UDI-DI: 06945664821285
510(k) Number: K142832
FDA product code: DQA
GMDN term: Pulse oximeter probe, reusable

Device class: Class II
Regulation number: 870.2700
GUDID distribution status: In Commercial Distribution

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Properties

Serial number

Other properties (14, all answered No)