Bt-500

by Bistos Co., Ltd.

Bt-500 (MKT-500-1509) is a Class II device made by Bistos Co., Ltd., cleared under FDA 510(k) K132543 on 3 Jul 2014 and listed in FDA GUDID since 3 Jun 2016 (UDI-DI 00887529000137), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00887529000137 UDI-DI	Date3 Jun 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK132543	Date3 Jul 2014Issued	StatusActive

Official records

AccessGUDID record UDI-DI 00887529000137
FDA 510(k) database 510(k) number K132543

Across registries

2 registries list this device

FDA 510(k) K132543 decided 3 Jul 2014 Active
FDA GUDID UDI-DI 00887529000137 listed 3 Jun 2016 Listed

Timeline

2 dated events

3 Jul 2014 Cleared FDA 510(k) K132543
3 Jun 2016 Listed FDA GUDID 00887529000137

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Conventional infant incubator
Model / Ref / Catalog: BT-500, MKT-500-1509

Primary DI / UDI-DI: 00887529000137
510(k) Number: K132543
FDA product code: FMZ
GMDN term: Conventional infant incubator

Device class: Class II
Regulation number: 880.5400
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)