COSMED Spiropalm

by C O S M E D SRL

COSMED Spiropalm is a Class II device made by C O S M E D SRL, cleared under FDA 510(k) K093174 on 26 Feb 2010 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 18052400180072), 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	Number18052400180072 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK093174	Date26 Feb 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 18052400180072
FDA 510(k) database 510(k) number K093174

Across registries

2 registries list this device

FDA 510(k) K093174 decided 26 Feb 2010 Active
FDA GUDID UDI-DI 18052400180072 listed 23 Sep 2016 Listed

Timeline

2 dated events

26 Feb 2010 Cleared FDA 510(k) K093174
23 Sep 2016 Listed FDA GUDID 18052400180072

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Cosmed
Generic name: Diagnostic spirometer, professional
Model / reference: Spiropalm

Primary DI / UDI-DI: 18052400180072
510(k) Number: K093174
FDA product code: BZG
GMDN term: Diagnostic spirometer, professional

Device class: Class II
Regulation number: 868.1840
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number

Other properties (13, all answered No)