510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140095Substantially Equivalent

Prime Zoom Stretcher

Stryker Corp., Portage MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140095 is the FDA 510(k) clearance record for PRIME ZOOM STRETCHER, a class II device, cleared for Stryker Corporation on under FDA product code INK (Stretcher, Wheeled, Powered). FDA records list 568 510(k) clearances for Stryker Corporation, from to . As of , FDA records show one recall naming K140095.

Clearance record

Decision date
Received
(126 days to decision)
Product code
INK Stretcher, Wheeled, Powered
Regulation
21 CFR 890.3690
Device class
Class II
Review panel
Physical Medicine
Applicant
Stryker Corporation 3800 E. Centre Ave., Portage MI
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code INK

Trailing 12 months

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

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