510(k) Report

FDA product code · Ophthalmic

Conformer, Ophthalmic, Biological Tissue

NQBClass II21 CFR 886.3130510(k) exempt1 decision since 20033 recalls

FDA lists NQB as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2003. 3 recalls name this code, 0 of them Class I. The most-cited predicate is K032104, named by 1 later device.

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 surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ophthalmic panel

Twenty years of NQB at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NQB

FDA has decided no NQB device since 2007.

Median 510(k) review, days · NQB

Too few NQB 510(k)s in any year since 2007 to give a median.

Recalls per year · NQB

3in 2020

2020: 3
2007high 3 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NQB

6in 2025

2019: 22020: 32021: 102023: 12025: 6
2007high 10 (2021) · low 0 (2007)2025

MAUDE reports naming product code NQB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—02
20200—33
20210—010
20220—00
20230—01
20240—00
20250—06
20260—0—
FIG. 1 — NQB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NQB? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NQB devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K032104AmniolensBio-Tissue, Inc. · 20031cites it

Which NQB devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K032104AmniolensBio-Tissue, Inc. · 20031generation

What has FDA decided in NQB lately?

  • K032104AmniolensBio-Tissue, Inc. · 20033 recalls

The one NQB decision →

What has been recalled in NQB lately?

  • K032104PROKERA, non-sterile - Product Usage: Biologic corneal bandage.TissueTech, Inc. · Nov 10, 2020Class II
  • K032104PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.TissueTech, Inc. · Nov 10, 2020Class II
  • K032104PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.TissueTech, Inc. · Nov 10, 2020Class II

Related product codes

Other codes under 21 CFR 886.3130.

HQN Conformer, OphthalmicNXM Prosthesis, Eyelid Spacer/Graft, BiologicQWU Prosthesis, Eyelid Spacer/Graft, Polymer