510(k) · Cleared
ClearedBarron Microkeratome System, Model B2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barron Precision Instruments, LLC · HNO Keratome, Ac-Powered
Cleared on Dec 2, 1998 as substantially equivalent to K974004 (Lasersight Technologies, Inc., 1998) and 3 other predicates after a 72-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Dec 2, 1998
- Review
- 72 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K935342 (1994). 9 ancestors in all, the oldest K860001 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
- 2 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
- 1 generation backK973294 Innovatome MicrokeratomeInnovative Optics, Inc. · 1997
- This deviceK983317 Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC · 1998
- Descendant · cites it directly · 0 of its ownK991124 Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K991124Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935342 | SCMD Keratome | S.C.M.D. Keratomes of Arizona | 1994 | — |
| −2 | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) | Plancon Instruments | 1997 | — |
| −1 | K973294 | Innovatome Microkeratome | Innovative Optics, Inc. | 1997 | — |
| 0 (this device) | K983317 | Barron Microkeratome System, Model B2000 | Barron Precision Instruments, LLC | 1998 | — |
| +1 | K991124 | Visijet Hydrokeratome, Model 50 | Visijet, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (4)
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 |
|---|---|---|---|
| * | K974004 | Automated Disposable Keratome (Adk)Summary page 2…ntification of legally marketed predicate devices to which equivalence is being claimed Company Device 510(k) ‘LaserSight Technologies . - Automated Disposable Keratome K974004 Hansa Research & Development Automated Corneal Shaper K913697 Innovative Optics, Inc. " INNOVATOME ' K973294 Micro Precision Ins… | 1998 |
| * | K913697 | Automatic Corneal ShaperSummary page 2…ivalence is being claimed Company Device 510(k) ‘LaserSight Technologies . - Automated Disposable Keratome K974004 Hansa Research & Development Automated Corneal Shaper K913697 Innovative Optics, Inc. " INNOVATOME ' K973294 Micro Precision Instrument Co Micro Refractive System Model 1000 K903912 Descrip… | 1991 |
| * | K973294 | Innovatome MicrokeratomeSummary page 2…) ‘LaserSight Technologies . - Automated Disposable Keratome K974004 Hansa Research & Development Automated Corneal Shaper K913697 Innovative Optics, Inc. " INNOVATOME ' K973294 Micro Precision Instrument Co Micro Refractive System Model 1000 K903912 Description of the Device The Barron Microkeratome -… | 1997 |
| * | K903912 | KeratomeSummary page 2…Research & Development Automated Corneal Shaper K913697 Innovative Optics, Inc. " INNOVATOME ' K973294 Micro Precision Instrument Co Micro Refractive System Model 1000 K903912 Description of the Device The Barron Microkeratome - System .consists of two components: a single-use Microkeratome and a Contr… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991124 | Visijet Hydrokeratome, Model 50 | 2000 | 0 |
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 4 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K991124 (Visijet, Inc., 2000) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K974004.
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 Barron Microkeratome System is indicated for performing
lamellar sectioning of the cornea.
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/K983317 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983317: Barron Microkeratome System, Model B2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983317
Report an extraction error
Are you the manufacturer?
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