510(k) · Cleared
Recalled · Class II · 2020Amniolens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Tissue, Inc. · NQB Conformer, Ophthalmic, Biological Tissue
Cleared on Dec 12, 2003 as substantially equivalent to K921221 (Storz Instrument Co., 1992) after a 157-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 12, 2003
- Review
- 157 days
- Class
- Class II
- Product code
- NQB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921221 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK921221 Sterile/Single Use Symblepharon RingStorz Instrument Co. · 1992
- This deviceK032104 AmniolensBio-Tissue, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK053622 Surgisis Ocular GraftIop, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK090078 Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK223074 CorNeat EverPatchCorneat Vision, Ltd. · 2023 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921221 | Sterile/Single Use Symblepharon Ring | Storz Instrument Co. | 1992 | — |
| 0 (this device) | K032104 | Amniolens | Bio-Tissue, Inc. | 2003 | — |
| +1 | K053622 | Surgisis Ocular Graft | Iop, Inc. | 2006 | — |
| +2 | K090078 | Kerasys Bioengineered Lamellar Patch Graft | Iop, Inc. | 2009 | — |
| +3 | K223074 | CorNeat EverPatch | Corneat Vision, Ltd. | 2023 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921221 | Sterile/Single Use Symblepharon RingSummary page 1…c Membrane Classification Name: Ophthalmic Conformer, 21 CFR §886.3130 Product Code: NQB Predicate Device: Symblepharon Ring, 510(k) # K921221 The ProKeraTM is a corneal-epithelial insert, consisting of an Device Description:… | 1992 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053622 | Surgisis Ocular Graft | 2006 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2020 | Class II | Z-0550-2021 | Under Investigation by firm | Potential exposure of product to microbial contamination. |
| Nov 10, 2020 | Class II | Z-0552-2021 | Under Investigation by firm | Potential exposure of product to microbial contamination. |
| Nov 10, 2020 | Class II | Z-0551-2021 | Under Investigation by firm | Potential exposure of product to microbial contamination. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K053622 (Iop, Inc., 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NQB devicesNQB Conformer, Ophthalmic, Biological Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQB
6in 2025
MAUDE reports naming product code NQB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 3 | 3 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ProKeraTM is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.
The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032104: Amniolens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032104
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026