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Injekt Syringe

by B. Braun Medical, Inc.

510(k) K063280

Injekt Syringe is a Class II device made by B. Braun Medical, Inc., cleared under FDA 510(k) K063280 on 17 Nov 2006, active as of 8 Nov 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063280 Date17 Nov 2006ClearedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2644-2023 FDA Class II initiated 7 Aug 2023
    • Ongoing Z-2643-2023 FDA Class II initiated 7 Aug 2023

    The sterile blister packaging may be damaged, and sterility may be compromised

Timeline

3 dated events

  1. Cleared FDA 510(k) K063280
  2. Recall initiated FDA recalls Z-2644-2023
  3. Recall initiated FDA recalls Z-2643-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FMF
FDA applicant
B.Braun Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 880.5860
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K063280

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K063280
UDI-DISize and differences
NORM-JECT® NJ-4606755BMS
B. Braun Melsungen Aktiengesellschaft
NJ-4606755BMS / NJ-4606755BMS04046955635825
Total Volume 10 mL
On the market

Similar devices

Other devices filed under FDA product code FMF (Syringe, Piston).

Other devices from B. Braun Medical, Inc.

See all devices from B. Braun Medical, Inc. →