510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032104Substantially Equivalent

Amniolens

Bio-Tissue, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032104 is the FDA 510(k) clearance record for AMNIOLENS, a class II device, cleared for Bio-Tissue, Inc. on under FDA product code NQB (Conformer, Ophthalmic, Biological Tissue). FDA's definition for product code NQB reads: "The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following...". FDA records list one 510(k) clearance for Bio-Tissue, Inc. As of , FDA records show 3 recalls naming K032104.

Clearance record

Decision date
Received
(157 days to decision)
Product code
NQB Conformer, Ophthalmic, Biological Tissue
Regulation
21 CFR 886.3130
Device class
Class II
Review panel
Ophthalmic
Applicant
Bio-Tissue, Inc. 1301 K St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQB

Trailing 12 months

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

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