510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K900054Substantially Equivalent

Kestrel Lens Case 1543-893S/p-1700-2611

Kestrel, Columbus IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900054 is the FDA 510(k) clearance record for KESTREL LENS CASE 1543-893S/P-1700-2611, a class II device, cleared for Kestrel on under FDA product code LRX (Case, Contact Lens). FDA records list 3 510(k) clearances for Kestrel, from to . As of , FDA records show no recalls naming K900054.

Clearance record

Decision date
Received
(27 days to decision)
Product code
LRX Case, Contact Lens
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Kestrel 3240 N. Indianapolis Rd., Columbus IN
Third party review
No

Clearances, product code LRX

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