Invos Cnn

Invos Cnn is a Class II device made by Covidien LP, cleared under FDA 510(k) K091224 on 9 Jul 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20884521106069), 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	Number20884521106069 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK091224	Date9 Jul 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 20884521106069
FDA 510(k) database 510(k) number K091224

Across registries

2 registries list this device

FDA 510(k) K091224 decided 9 Jul 2009 Active
FDA GUDID UDI-DI 20884521106069 listed 24 Sep 2016 Listed

Timeline

2 dated events

9 Jul 2009 Cleared FDA 510(k) K091224
24 Sep 2016 Listed FDA GUDID 20884521106069

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Invos
Generic name: Cerebral oximeter sensor, single-use
Model / reference: CNN

Primary DI / UDI-DI: 20884521106069
510(k) Number: K091224
FDA product code: MUD
GMDN term: Cerebral oximeter sensor, single-use

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

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Properties

Single use
Prescription use
Lot / batch number

Other properties (12, all answered No)