510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K051985Substantially Equivalent

Biovalve Mini-Ject Needlefree Injector

Biovalve Technologies, Inc., Westborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051985 is the FDA 510(k) clearance record for BIOVALVE MINI-JECT NEEDLEFREE INJECTOR, a class II device, cleared for Biovalve Technologies, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list 3 510(k) clearances for Biovalve Technologies, Inc., from to . As of , FDA records show no recalls naming K051985.

Clearance record

Decision date
Received
(26 days to decision)
Product code
KZE Injector, Fluid, Non-Electrically Powered
Regulation
21 CFR 880.5430
Device class
Class II
Review panel
General Hospital
Applicant
Biovalve Technologies, Inc. 155 Flanders Rd., Westborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZE

Trailing 12 months

FDA records hold no clearances under product code KZE in the trailing twelve months.

FDA records show no clearances under product code KZE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260