510(k) · Cleared
ClearedPegasus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology Laboratories, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 11, 1994 after a 356-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 1,063 devices in its family, counting itself, have a Class I recall. 1,062 later devices descend from it.
- Decided
- Oct 11, 1994
- Review
- 356 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
1,062 later devices descend from it, 4 citing it directly. 3 of the 1,063 devices in this family, counting this one, have a Class I recall.
- This deviceK935009 PegasusAdvanced Technology Laboratories, Inc. · 1994
- Descendant · cites it directly · 1,024 of its ownK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- Descendant · cites it directly · 899 of its ownK991872 Lynx Ultrasound SystemEcton, Inc. · 1999
- Descendant · cites it directly · 899 of its ownK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- Descendant · 2 generations on · 898 of its ownK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- Descendant · 3 generations on · 827 of its ownK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
Showing 5 of 1,062 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,062 · See all- K964309Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997 · cites it directly1,024descendants
- K991872Lynx Ultrasound SystemEcton, Inc. · 1999 · cites it directly899descendants
- K982800Ecton Lynx Ultrasound SystemEcton, Inc. · 1998 · cites it directly899descendants
- K021497Cypress Ultrasound SystemAcuson Corp. · 2002 · 2 generations on898descendants
- K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on827descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935009 | Pegasus | Advanced Technology Laboratories, Inc. | 1994 | — |
| +1 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| +1 | K991872 | Lynx Ultrasound System | Ecton, Inc. | 1999 | — |
| +1 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| +2 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| +3 | K042055 | Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 11 | 0 |
| 2008 | 15 | 0 |
| 2009 | 21 | 0 |
| 2010 | 18 | 0 |
| 2011 | 29 | 0 |
| 2012 | 38 | 0 |
| 2013 | 43 | 0 |
| 2014 | 56 | 0 |
| 2015 | 61 | 0 |
| 2016 | 68 | 0 |
| 2017 | 81 | 0 |
| 2018 | 70 | 0 |
| 2019 | 56 | 0 |
| 2020 | 79 | 1 |
| 2021 | 56 | 0 |
| 2022 | 60 | 0 |
| 2023 | 61 | 0 |
| 2024 | 63 | 0 |
| 2025 | 87 | 2 |
| 2026 | 57 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1,062)
See all 1,0624 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 10 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K964309 (Hewlett-Packard Co., 1997) has gone furthest, with 1,024 descendants of its own.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
https://510kreport.com/device/K935009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K935009: Pegasus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935009
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026