510(k) · Cleared
ClearedLeica FL800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leica Biosystems Richmond · IZI System, X-Ray, Angiographic
Cleared on Aug 19, 2014 as substantially equivalent to K061871 (Leica Microsystems, Inc., 2006) and 1 other predicate after a 110-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.
- Decided
- Aug 19, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K944261 (1994). 9 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 5 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 4 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 3 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 2 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 1 generation backK080612 Leica FL800Leica Microsystems (Schweiz) AG · 2008
- This deviceK141136 Leica FL800Leica Biosystems Richmond · 2014
- Descendant · cites it directly · 0 of its ownK190772 SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 0 of its ownK181537 GLOW800Leica Microsystems (Schweiz) AG · 2018
- Descendant · cites it directly · 0 of its ownK170239 Leica FL560Leica Microsystems (Schweiz) AG · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −5 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −4 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −3 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −2 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −1 | K080612 | Leica FL800 | Leica Microsystems (Schweiz) AG | 2008 | — |
| 0 (this device) | K141136 | Leica FL800 | Leica Biosystems Richmond | 2014 | — |
| +1 | K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K181537 | GLOW800 | Leica Microsystems (Schweiz) AG | 2018 | — |
| +1 | K170239 | Leica FL560 | Leica Microsystems (Schweiz) AG | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (2)
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 4…sequent product code is EPT (Surgical Microscope and Accessory) Devices for Which Substantial Equivalence in Claimed: Leica Microsystems (Schweiz) AG, Leica FL800 (K061871) Leica Microsystems (Schweiz) AG, Leica FL800 (K080612) Device Description: The Leica FL800 device is an accessory to the L… | 2006 |
| * | K080612 | Leica FL800Summary page 4…ry) Devices for Which Substantial Equivalence in Claimed: Leica Microsystems (Schweiz) AG, Leica FL800 (K061871) Leica Microsystems (Schweiz) AG, Leica FL800 (K080612) Device Description: The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope… | 2008 |
What descends from it? (3)
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 20 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 9 ancestors have a recall of any class.
- Of its descendants, K190772 (Olympus Medical Systems Corp., 2019) has gone furthest, with 0 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. 2014, 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 Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and 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/K141136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141136: Leica FL800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141136
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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