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
K801937Substantially Equivalent

Blepharometer

Aztec Medical Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801937 is the FDA 510(k) clearance record for BLEPHAROMETER, a class I device, cleared for Aztec Medical Products, Inc. on under FDA product code HOE (Caliper, Ophthalmic). FDA records list 5 510(k) clearances for Aztec Medical Products, Inc., from to . As of , FDA records show no recalls naming K801937.

Clearance record

Decision date
Received
(35 days to decision)
Product code
HOE Caliper, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Aztec Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
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