510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052314Substantially Equivalent

Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large

Dynarex Corp., Orangeburg NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052314 is the FDA 510(k) clearance record for DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE, a class II device, cleared for Dynarex Corp. on under FDA product code HIB (Speculum, Vaginal, Nonmetal). FDA records list 27 510(k) clearances for Dynarex Corp., from to . As of , FDA records show no recalls naming K052314.

Clearance record

Decision date
Received
(76 days to decision)
Product code
HIB Speculum, Vaginal, Nonmetal
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Dynarex Corp. 10 Glenshaw St., Orangeburg NY
510(k) summary
Summary PDF
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