510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011532Substantially Equivalent

Mityvac

Prism Enterprises, Inc., Washington DC / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K011532 is the FDA 510(k) clearance record for MITYVAC, a class II device, cleared for Prism Enterprises, Inc. on under FDA product code HDB (Extractor, Vacuum, Fetal). FDA records list 4 510(k) clearances for Prism Enterprises, Inc., from to . As of , FDA records show 4 recalls naming K011532.

Clearance record

Decision date
Received
(73 days to decision)
Product code
HDB Extractor, Vacuum, Fetal
Regulation
21 CFR 884.4340
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Prism Enterprises, Inc. 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code HDB

Trailing 12 months

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

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