Pfm 4300

by Vitalograph Ireland, Ltd. 8 variants

Pfm 4300 is a Class I device made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K781922 on 13 Feb 1979 and listed in FDA GUDID since 8 Dec 2016 (UDI-DI 05099169439030), 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	Number05099169439030 UDI-DI	Date8 Dec 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK781922	Date13 Feb 1979Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05099169439030
FDA 510(k) database 510(k) number K781922

Across registries

2 registries list this device

FDA 510(k) K781922 decided 13 Feb 1979 Active
FDA GUDID UDI-DI 05099169439030 listed 8 Dec 2016 Listed

Timeline

2 dated events

13 Feb 1979 Cleared FDA 510(k) K781922
8 Dec 2016 Listed FDA GUDID 05099169439030

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Pfm
Generic name: Peak flow meter, manual
Model / reference: 4300

Primary DI / UDI-DI: 05099169439030
510(k) Number: K781922
FDA product code: BXW
GMDN term: Peak flow meter, manual

Device class: Class I
Regulation number: 868.1870
GUDID distribution status: In Commercial Distribution

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See all devices from Vitalograph Ireland, Ltd. →

Properties

Lot / batch number

Other properties (14, all answered No)