510(k) · Cleared
ClearedLeica FL800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leica Microsystems (Schweiz) AG · IZI System, X-Ray, Angiographic
Cleared on May 9, 2008 as substantially equivalent to K061871 (Leica Microsystems, Inc., 2006) and 2 other predicates after a 66-day review. Its family tree reaches back 5 generations to 1994. 9 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 66 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K944261 (1994). 8 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 4 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 3 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 2 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 1 generation backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- This deviceK080612 Leica FL800Leica Microsystems (Schweiz) AG · 2008
- Descendant · cites it directly · 4 of its ownK100468 Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH · 2010
- Descendant · cites it directly · 3 of its ownK141136 Leica FL800Leica Biosystems Richmond · 2014
- Descendant · 2 generations on · 1 of its ownK202391 DIR 800Aesculap, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK243077 Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2025
- Descendant · 2 generations on · 0 of its ownK231986 Modus IRSynaptive Medical, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K100468Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH · 2010 · cites it directly4descendants
- K141136Leica FL800Leica Biosystems Richmond · 2014 · cites it directly3descendants
- K202391DIR 800Aesculap, Inc. · 2021 · 2 generations on1descendant
- K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2025 · 3 generations on0descendants
- K231986Modus IRSynaptive Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −4 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −3 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −2 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −1 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| 0 (this device) | K080612 | Leica FL800 | Leica Microsystems (Schweiz) AG | 2008 | — |
| +1 | K100468 | Zeiss Infrared 800 with Flow 800 Option | Carl Zeiss Surgical GmbH | 2010 | — |
| +1 | K141136 | Leica FL800 | Leica Biosystems Richmond | 2014 | — |
| +2 | K202391 | DIR 800 | Aesculap, Inc. | 2021 | — |
| +3 | K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025 | — |
| +2 | K231986 | Modus IR | Synaptive Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 IZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K061871 | Leica Model FL800Summary page 1…tantial.Equivalence: The Leica FL,800 is an existing device which was granted market clearance by the FD)A following the submission of a 510(k) pre-market notification (K06 1871). Leica Microsystems seeks only an extension of Use into cor7onary vascular and bypass surgery, as well as plastic land reconstru… | 2006 |
| * | K071037 | Spy Intra-Operative Imaging System, Model SP2000Summary page 2…The 510(k) numbers for the predicate devices are the following: Leica FL800 - 510(k) No. K061871 dated September 20, 2006. Spy Imaging System - 510(k) No. K071037 dated May 10, 2007 and K072222 dated September 7, 2007. The Leica FL800 is an existing device which was granted market cl… | 2007 |
| * | K072222 | Spy Fluorescent Imaging SystemSummary page 1…ices focr Which Substantial l.ciuivalence is Clainicd * Leica Microsystems, Inc., Leicea FL800 (KO61871I% * Novadaq Technologies, Inc., SPY Imaging System ('KO71037 and K072222,). Device DescripJtion: The Leica FL1800 device is ail accessory to the Leica. surgical microscopes. It allows the surgical mic… | 2007 |
What descends from it? (9)
3 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 14 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K100468 (Carl Zeiss Surgical GmbH, 2010) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K061871.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Leica FL800 is a surgical microscope accessory used in viewing bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080612 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080612: Leica FL800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080612
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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