510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K992308Substantially Equivalent

Oocyte Retrieval Needle Set, Model 90138

Lifetek Medical, Inc., Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992308 is the FDA 510(k) clearance record for OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138, a class II device, cleared for Lifetek Medical, Inc. on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 2 510(k) clearances for Lifetek Medical, Inc., from to . As of , FDA records show no recalls naming K992308.

Clearance record

Decision date
Received
(66 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Lifetek Medical, Inc. P.O. Box 560, Stillwater MN
510(k) summary
Summary
Third party review
No

Clearances, product code MQE

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