510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882902Substantially Equivalent

Qrk 100, Qualitative Ring Keratoscope

Technitex, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882902 is the FDA 510(k) clearance record for QRK 100, QUALITATIVE RING KERATOSCOPE, a class I device, cleared for Technitex, Inc. on under FDA product code HLR (Keratoscope, Battery-Powered). FDA records list 3 510(k) clearances for Technitex, Inc., from to . As of , FDA records show no recalls naming K882902.

Clearance record

Decision date
Received
(23 days to decision)
Product code
HLR Keratoscope, Battery-Powered
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Technitex, Inc. 11211 Richmond Ave., Suite, Houston TX
Third party review
No

Clearances, product code HLR

Trailing 12 months

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

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