Andesfit ADF-MSA100

by Andesfit Limited

Andesfit ADF-MSA100 is a Class II device made by Andesfit Limited, cleared under FDA 510(k) K170281 on 6 Oct 2017 and listed in FDA GUDID since 9 Sep 2019 (UDI-DI 00146191010005), 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	Number00146191010005 UDI-DI	Date9 Sep 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK170281	Date6 Oct 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00146191010005
FDA 510(k) database 510(k) number K170281

Across registries

2 registries list this device

FDA 510(k) K170281 decided 6 Oct 2017 Active
FDA GUDID UDI-DI 00146191010005 listed 9 Sep 2019 Listed

Timeline

2 dated events

6 Oct 2017 Cleared FDA 510(k) K170281
9 Sep 2019 Listed FDA GUDID 00146191010005

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Andesfit
Generic name: Diagnostic spirometer, professional
Model / reference: ADF-MSA100

Primary DI / UDI-DI: 00146191010005
510(k) Number: K170281
FDA product code: BZH
GMDN term: Diagnostic spirometer, professional

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

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Properties

Convenience kit
Lot / batch number
Manufacturing date

Other properties (12, all answered No)