510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920177Substantially Equivalent

Versa-Vial

Bioteque America Inc, Levittown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920177 is the FDA 510(k) clearance record for VERSA-VIAL, a class II device, cleared for Bioteque America, Inc. on under FDA product code DQF (Actuator, Syringe, Injector Type). FDA records list 10 510(k) clearances for Bioteque America, Inc., from to . As of , FDA records show no recalls naming K920177.

Clearance record

Decision date
Received
(181 days to decision)
Product code
DQF Actuator, Syringe, Injector Type
Regulation
21 CFR 870.1670
Device class
Class II
Review panel
Cardiovascular
Applicant
Bioteque America, Inc. 51 Rainlily Rd., Levittown PA
510(k) summary
Summary
Third party review
No

Clearances, product code DQF

Trailing 12 months

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

FDA records show no clearances under product code DQF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DQF, 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