510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881094Substantially Equivalent

Koi(tm) Blade Gauge, Model Koi-132

CooperVision, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881094 is the FDA 510(k) clearance record for KOI(TM) BLADE GAUGE, MODEL KOI-132, a class I device, cleared for CooperVision, Inc. on under FDA product code HOE (Caliper, Ophthalmic). FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K881094.

Clearance record

Decision date
Received
(17 days to decision)
Product code
HOE Caliper, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
CooperVision, Inc. Coopervision Cilco, Bellevue WA
Third party review
No

Clearances, product code HOE

Trailing 12 months

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

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