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Kbmed SBCN25-1

by KB Medical (group), Inc. 2 variants

Kbmed SBCN25-1 is a Class II device made by KB Medical (group), Inc., cleared under FDA 510(k) K232881 on 22 Dec 2023 and listed in FDA GUDID since 21 May 2025 (UDI-DI 00850016172938), 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

510(k) K232881

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850016172938 UDI-DI Date21 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK232881 Date22 Dec 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232881 decided 22 Dec 2023 Active
  • FDA GUDID UDI-DI 00850016172938 listed 21 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232881
  2. Listed FDA GUDID 00850016172938

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Kbmed
Generic name
Blood collection set, invasive
Model / reference
SBCN25-1
Primary DI / UDI-DI
00850016172938
510(k) Number
FDA product code
JKA
GMDN term
Blood collection set, invasive
Device class
Class II
Regulation number
862.1675
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Blood collection set, invasive.

Other devices from KB Medical (group), Inc.

  • Kbmed SN1B-2525

    Class II
  • Kbmed SN1B-2125

    Class II
  • Kbmed ES3

    Class II
  • Kbmed SBCN23-1H

    Class II

See all devices from KB Medical (group), Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)