510(k) · Cleared
ClearedGLOW800
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 Sep 7, 2018 as substantially equivalent to K141136 (Leica Biosystems Richmond, 2014) after an 88-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Sep 7, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K944261 (1994). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 6 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 5 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 4 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 3 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 2 generations backK080612 Leica FL800Leica Microsystems (Schweiz) AG · 2008
- 1 generation backK141136 Leica FL800Leica Biosystems Richmond · 2014
- This deviceK181537 GLOW800Leica Microsystems (Schweiz) AG · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −6 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −5 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −4 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −3 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −2 | K080612 | Leica FL800 | Leica Microsystems (Schweiz) AG | 2008 | — |
| −1 | K141136 | Leica FL800 | Leica Biosystems Richmond | 2014 | — |
| 0 (this device) | K181537 | GLOW800 | Leica Microsystems (Schweiz) AG | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | K141136 | Leica FL800Summary page 4…Sankt Gallen 9435, Switzerland Telephone Number +41 71 726 32 45 Preparation Date September 7th, 2018 Predicate Device K141136 Leica FL800 ULT and FL800 21 CFR 892.1600, system, x-ray, angiographic, IZI product code Device De… | 2014 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141136.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181537: GLOW800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181537
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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