Nellcor SC-A

Nellcor SC-A is a Class II device made by Covidien LP, cleared under FDA 510(k) K030930 on 23 May 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20884522042458), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number20884522042458 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK030930	Date23 May 2003Decided	StatusActive

Official records

AccessGUDID record UDI-DI 20884522042458
FDA 510(k) database 510(k) number K030930

Across registries

2 registries list this device

FDA 510(k) K030930 decided 23 May 2003 Active
FDA GUDID UDI-DI 20884522042458 listed 24 Sep 2016 Listed

Timeline

2 dated events

23 May 2003 Cleared FDA 510(k) K030930
24 Sep 2016 Listed FDA GUDID 20884522042458

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Nellcor
Generic name: Pulse oximeter probe, single-use
Model / reference: SC-A

Primary DI / UDI-DI: 20884522042458
510(k) Number: K030930
FDA product code: DQA
GMDN term: Pulse oximeter probe, single-use

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

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)