FDA product code NQB: Conformer, Ophthalmic, Biological Tissue
NQB is the FDA product code for conformer, ophthalmic, biological tissue. It is a Class II device, regulated under 21 CFR 886.3130 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NQB. The average 510(k) review took 157 days (median 157). FDA has posted 3 recalls for NQB devices.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Conformer, Ophthalmic, Biological Tissue |
| Device class | Class II |
| Regulation | 21 CFR 886.3130 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| Implant | Yes |
Compare with all 510(k) review times · Search every NQB clearance
Top NQB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Tissue, Inc. | 1 | 2003-12-12 |
Most recent NQB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032104 | Bio-Tissue, Inc. | AMNIOLENS | 2003-12-12 | 157 |
Recalls for NQB devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-11-10.
| Year | Recalls |
|---|---|
| 2020 | 3 |
Frequently asked questions
What is FDA product code NQB?
NQB is the FDA product code for conformer, ophthalmic, biological tissue. It is a Class II device, regulated under 21 CFR 886.3130 and reviewed by the Ophthalmic panel.
What device class is NQB?
Class II, regulation 21 CFR 886.3130. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NQB?
Across 1 cleared submissions the average was 157 days from receipt to decision (median 157).
Which companies have the most NQB clearances?
Bio-Tissue, Inc. (1).
Have NQB devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2020-11-10.
Next steps
- Run an FDA pathway report with predicate devices for product code NQB
- Run a recall and safety report across every NQB manufacturer
- Watch product code NQB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times