510(k) · Cleared
ClearedExplorer Air II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgvision GmbH · IZI System, X-Ray, Angiographic
Cleared on Feb 25, 2022 as substantially equivalent to K182907 (Novadaq Technologies Ulc. (Now A Part of Stryker), 2019) after a 59-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 25, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944261 (1994). 23 ancestors in all, the oldest K860913 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 7 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 6 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 5 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 4 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 3 generations backK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- 2 generations backK100371 Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc. · 2011
- 1 generation backK182907 SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
- This deviceK214097 Explorer Air IISurgvision GmbH · 2022
- Descendant · cites it directly · 1 of its ownK222240 Explorer Air® IISurgvision GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK234090 EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape…Surgvision GmbH · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −7 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −6 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −5 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −4 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −3 | K073088 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| −2 | K100371 | Spy Intra-Operative Imaging System | Novadaq Technologies, Inc. | 2011 | — |
| −1 | K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019 | — |
| 0 (this device) | K214097 | Explorer Air II | Surgvision GmbH | 2022 | — |
| +1 | K222240 | Explorer Air® II | Surgvision GmbH | 2023 | — |
| +2 | K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K182907 | SPY Elite Intraoperative Perfusion Assessment SystemSummary page 4…e SPY Elite Intraoperative Perfusion Novadaq Technologies ULC., January 23, K182907 Assessment System now a part of Stryker 2019 Device Description EXPLORER AIR® I… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222240 | Explorer Air® II | 2023 | 1 |
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 28 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 15 of the 23 ancestors have a recall of any class.
- Of its descendants, K222240 (Surgvision GmbH, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K182907.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214097: Explorer Air II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214097
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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