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
K001098Substantially Equivalent

Pro.duct Health Micro-Stylet, Model Sty01

Pro. Duct Health, Inc., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001098 is the FDA 510(k) clearance record for PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01, a class II device, cleared for Pro. Duct Health, Inc. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 2 510(k) clearances for Pro. Duct Health, Inc., from to . As of , FDA records show no recalls naming K001098.

Clearance record

Decision date
Received
(44 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Pro. Duct Health, Inc. 1360 Willow Rd., Suite 201, Menlo Park CA
510(k) summary
Summary
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260