510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873440Substantially Equivalent

Rule, Pupillary

Allegheny Plastics, Inc., Coraopolis PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873440 is the FDA 510(k) clearance record for RULE, PUPILLARY, a class I device, cleared for Allegheny Plastics, Inc. on under FDA product code HMM (Distometer). FDA records list one 510(k) clearance for Allegheny Plastics, Inc. As of , FDA records show no recalls naming K873440.

Clearance record

Decision date
Received
(25 days to decision)
Product code
HMM Distometer
Regulation
21 CFR 886.1190
Device class
Class I
Review panel
Ophthalmic
Applicant
Allegheny Plastics, Inc. Thorn Run Rd. & Rt 51, Coraopolis PA
Third party review
No

Clearances, product code HMM

Trailing 12 months

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

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