510(k) · Cleared
ClearedCarriazo-Pendular Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schwind Eye-Tech-Solutions GmbH & Co. KG · HNO Keratome, Ac-Powered
Cleared on Aug 1, 2008 as substantially equivalent to K032910 (Schwind Eye-Tech-Solutions GmbH & Co. KG, 2004) and 2 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Aug 1, 2008
- Review
- 14 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K935342 (1994). 25 ancestors in all, the oldest K860001 (1986). No later device cites it as a predicate yet.
- Root · 5 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
- 4 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
- 3 generations backK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
- 2 generations backK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
- 1 generation backK032910 Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004
- This deviceK082043 Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935342 | SCMD Keratome | S.C.M.D. Keratomes of Arizona | 1994 | — |
| −4 | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) | Plancon Instruments | 1997 | — |
| −3 | K980924 | Plancon Microlamellar Keratome Evolution | Plancon Instruments | 1998 | — |
| −2 | K981741 | Carriazo Barraquer Microkeratome | Moria, Inc. | 1998 | — |
| −1 | K032910 | Carriazo Pendular | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004 | — |
| 0 (this device) | K082043 | Carriazo-Pendular Microkeratome | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2005 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032910 | Carriazo PendularSummary page 1…Rolf Schwind May 2007 Carriazo-Pendular Microkeratome Keratome (microkeratome) 21 CFR 886.4370 Class | Product Code: HNO Panel: 86 Carriazo-Pendular Microkeratome (K032910) BD K-4000™Microkeratome (K023092) INTRALASE FS Laser (K0O41893) SCHUJ~flD CRRRIIqClZO -PIFtDUL1R… | 2004 |
| * | K023092 | BD K-4000 Microkeratome SystemSummary page 1…Pendular Microkeratome Keratome (microkeratome) 21 CFR 886.4370 Class | Product Code: HNO Panel: 86 Carriazo-Pendular Microkeratome (K032910) BD K-4000™Microkeratome (K023092) INTRALASE FS Laser (K0O41893) SCHUJ~flD CRRRIIqClZO -PIFtDUL1R… | 2002 |
| * | K041893 | Intralase FS Laser | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 25 ancestors have a recall of any class.
- 2 other devices also cite its predicate K032910.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Carriazo Pendular Microkeratome indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in 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/K082043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082043: Carriazo-Pendular Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082043
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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