510(k) · Cleared
ClearedPegasus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.M. Surgical, Inc. · HRX Arthroscope
Cleared on Jul 17, 2019 as substantially equivalent to K162475 (Trice Medical, 2016) after a 58-day review. Its family tree reaches back 9 generations to 1983.
- Decided
- Jul 17, 2019
- Review
- 58 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K833587 (1983). 26 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 9 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 5 generations between
- 3 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 2 generations backK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- 1 generation backK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- This deviceK191345 Pegasus SystemA.M. Surgical, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 8 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 7 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 6 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 5 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 4 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- 3 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 2 generations backK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- 1 generation backK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- This deviceK191345 Pegasus SystemA.M. Surgical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −8 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −7 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −6 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −5 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −4 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| −3 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| −2 | K141119 | Camera Enabled Probe | Trice Medical, Inc. | 2014 | — |
| −1 | K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | 2016 | — |
| 0 (this device) | K191345 | Pegasus System | A.M. Surgical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K162475 | mi-eye 2, mi-eye 2 monitorSummary page 4…II Product Code: HRX Special Controls or Device Specific Standards: N/A III. PREDICATE DEVICE The subject device is equivalent to the predicate K162475 mi-eye 2. No reference devices were used in this submission. IV. DEVICE DESCRIPTION The Pegasus System is a p… | 2016 |
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 36 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 26 ancestors have a recall of any class.
- 3 other devices also cite its predicate K162475.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Pegasus System 1s indicated for diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191345: Pegasus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191345
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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