510(k) · Cleared
ClearedCarriazo Barraquer Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moria, Inc. · HMY Keratome, Battery-Powered
Cleared on Jul 24, 1998 as substantially equivalent to K980924 (Plancon Instruments, 1998) and 2 other predicates after a 67-day review. Its family tree reaches back 3 generations to 1994. 63 later devices descend from it.
- Decided
- Jul 24, 1998
- Review
- 67 days
- Class
- Class I
- Product code
- HMY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K935342 (1994). 6 ancestors in all, the oldest K913697 (1991). 63 later devices descend from it, 3 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 backK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
- This deviceK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
- Descendant · cites it directly · 58 of its ownK032910 Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004
- Descendant · 2 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- Descendant · 3 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 4 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- Descendant · 4 generations on · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004 · cites it directly58descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 2 generations on56descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 3 generations on51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 4 generations on47descendants
- K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 4 generations on31descendants
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 | K980924 | Plancon Microlamellar Keratome Evolution | Plancon Instruments | 1998 | — |
| 0 (this device) | K981741 | Carriazo Barraquer Microkeratome | Moria, Inc. | 1998 | — |
| +1 | K032910 | Carriazo Pendular | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004 | — |
| +2 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| +3 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +4 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| +4 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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 HMY? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980924 | Plancon Microlamellar Keratome EvolutionSummary page 1…e is being claimed to the following legally marketed devices a. Company: PLANCON INSTRUMENTS Device : PLANCON microlamellar keratome : EVOLUTION power unit 510 (K) : K 980 924 b. Company: HANSA Research & Develpment Device : Automatic corneal shaper 510 (K) : K913 697 c. Company: HANSA Research & Devel… | 1998 |
| * | K913697 | Automatic Corneal ShaperSummary page 1…Device : PLANCON microlamellar keratome : EVOLUTION power unit 510 (K) : K 980 924 b. Company: HANSA Research & Develpment Device : Automatic corneal shaper 510 (K) : K913 697 c. Company: HANSA Research & Development Device : Hansatome 510 (K) : K 972 808 MORIA CARRIAZO BARRAQUER micro… | 1991 |
| * | K972808 | Hansatome MicrokeratomeSummary page 1…924 b. Company: HANSA Research & Develpment Device : Automatic corneal shaper 510 (K) : K913 697 c. Company: HANSA Research & Development Device : Hansatome 510 (K) : K 972 808 MORIA CARRIAZO BARRAQUER microkeratome May 15, 1998 Premarket Notification Section 5 page 2 5. Device descript… | 1997 |
What descends from it? (63)
See all 633 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 4 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K032910 (Schwind Eye-Tech-Solutions GmbH & Co. KG, 2004) has gone furthest, with 58 descendants of its own.
- 3 other devices also cite its predicate K980924.
How does its category compare?
All HMY devicesHMY Keratome, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HMY
FDA has decided no HMY device since 2007.
Median 510(k) review, days · HMY
Too few HMY 510(k)s in any year since 2007 to give a median.
Recalls per year · HMY
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HMY
1in 2025
MAUDE reports naming product code HMY, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CARRIAZO BARRAQUER microkeratome is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.
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/K981741 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981741: Carriazo Barraquer Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981741
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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