510(k) · Cleared
ClearedInnovatome Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Optics, Inc. · HNO Keratome, Ac-Powered
Cleared on Oct 3, 1997 as substantially equivalent to K960395 (Plancon Instruments, 1996) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it.
- Decided
- Oct 3, 1997
- Review
- 31 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K935342 (1994). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
- 1 generation backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
- This deviceK973294 Innovatome MicrokeratomeInnovative Optics, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK990900 Microkeratome, Model MK-2000Nidek, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK983317 Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC · 1998
- Descendant · 2 generations on · 0 of its ownK032297 Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK022205 Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK991124 Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000
Most influential descendants
Showing 5 of 5 · See all- K990900Microkeratome, Model MK-2000Nidek, Inc. · 1999 · cites it directly2descendants
- K983317Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC · 1998 · cites it directly1descendant
- K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003 · 2 generations on0descendants
- K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002 · 2 generations on0descendants
- K991124Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935342 | SCMD Keratome | S.C.M.D. Keratomes of Arizona | 1994 | — |
| −1 | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) | Plancon Instruments | 1997 | — |
| 0 (this device) | K973294 | Innovatome Microkeratome | Innovative Optics, Inc. | 1997 | — |
| +1 | K990900 | Microkeratome, Model MK-2000 | Nidek, Inc. | 1999 | — |
| +1 | K983317 | Barron Microkeratome System, Model B2000 | Barron Precision Instruments, LLC | 1998 | — |
| +2 | K032297 | Disposable N-PE Mickrokeratome Blades | Oasis Medical, Inc. | 2003 | — |
| +2 | K022205 | Disposable N-PE Microkeratome Blades | Oasis Medical, Inc. | 2002 | — |
| +2 | K991124 | Visijet Hydrokeratome, Model 50 | Visijet, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 HNO? 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K940155 | FDA’s K940155 is Enline Endoscopic Surgical Instruments Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1994 |
| * | K960395 | Plancon Mircolamellar KeratomeSummary page 3…175 microns | | 130-180 microns not statedx | Lg}ndications see below { | see below | sae below L for reference * copy of Safety and Effectiveness Summary for K960395 is attached for reference - predicate devices INDICATIONS INNOVATOME!Y Microkeratome: Chiron Microkeratome: Plancon Microlam… | 1996 |
| * | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Summary page 4…equivalent to the claimed legally marketed predicate devices such as the Chiron microkeratome (K3941550), the Plancon Microlamellar keratome (as described in K960395 and K970377), or the unnamed microkeratome cited in K960395. Attachment 1 - Chiron Brochure (page 6 in this application) Attachment 2 - Publ… | 1997 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K990900 (Nidek, Inc., 1999) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K960395.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNO
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HNO
Too few HNO 510(k)s in any year since 2007 to give a median.
Recalls per year · HNO
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNO
7in 2024
MAUDE reports naming product code HNO, 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 | — | 2 | 32 |
| 2008 | 1 | — | 2 | 31 |
| 2009 | 1 | — | 0 | 85 |
| 2010 | 0 | — | 0 | 84 |
| 2011 | 0 | — | 4 | 90 |
| 2012 | 0 | — | 0 | 100 |
| 2013 | 0 | — | 0 | 353 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 966 |
| 2016 | 0 | — | 0 | 1,397 |
| 2017 | 1 | — | 0 | 2,112 |
| 2018 | 1 | — | 0 | 2,265 |
| 2019 | 0 | — | 0 | 816 |
| 2020 | 0 | — | 0 | 405 |
| 2021 | 0 | — | 0 | 72 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INNOVATOME" microkeratome system 1s indicated for the resection of a circulal anterior lamellar flap.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973294 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973294: Innovatome Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973294
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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