1235-0-12

by Salter Labs, LLC

1235-0-12 is a peak flow meter (FDA Class II; FDA product code BZH, Meter, Peak Flow, Spirometry) made by Salter Labs, LLC, cleared under FDA 510(k) K952713 on 29 Mar 1996 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00607411001260), 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	Number00607411001260 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK952713	Date29 Mar 1996Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00607411001260
FDA 510(k) database 510(k) number K952713

Across registries

2 registries list this device

FDA 510(k) K952713 decided 29 Mar 1996 Active
FDA GUDID UDI-DI 00607411001260 listed 24 Sep 2016 Listed

Timeline

2 dated events

29 Mar 1996 Cleared FDA 510(k) K952713
24 Sep 2016 Listed FDA GUDID 00607411001260

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Peak flow meter, manual
Model / Ref / Catalog: 1235-0-12

Primary DI / UDI-DI: 00607411001260
510(k) Number: K952713
FDA product code: BZH
GMDN term: Peak flow meter, manual

Device class: Class II
Regulation number: 868.1860
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)