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
K933521Substantially Equivalent

Speculum

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

K933521 is the FDA 510(k) clearance record for SPECULUM, a class II device, cleared for Bioteque America, Inc. on under FDA product code HIB (Speculum, Vaginal, Nonmetal). FDA records list 10 510(k) clearances for Bioteque America, Inc., from to . As of , FDA records show no recalls naming K933521.

Clearance record

Decision date
Received
(230 days to decision)
Product code
HIB Speculum, Vaginal, Nonmetal
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Bioteque America, Inc. 340 E. Maple Ave., #204-C, Langhorne PA
510(k) summary
Statement
Third party review
No

Clearances, product code HIB

Trailing 12 months
1 clearance under product code HIB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260