510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913324Substantially Equivalent

Mityvac(r) Saftisoft Obstetrical Vacuum Deliv Kit

Neward Enterprises, Inc., Cucamonga CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913324 is the FDA 510(k) clearance record for MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT, a class II device, cleared for Neward Enterprises, Inc. on under FDA product code HDB (Extractor, Vacuum, Fetal). FDA records list 8 510(k) clearances for Neward Enterprises, Inc., from to . As of , FDA records show no recalls naming K913324.

Clearance record

Decision date
Received
(333 days to decision)
Product code
HDB Extractor, Vacuum, Fetal
Regulation
21 CFR 884.4340
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Neward Enterprises, Inc. P.O. Box 725, Cucamonga CA
510(k) summary
Statement
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