510(k) · Cleared
Recalled · Class II · 2024Flosimple Arthroscopy Pump A120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine AG · HRX Arthroscope
Cleared on Dec 14, 2006 as substantially equivalent to K030402 (W.O.M. World of Medicine AG, 2003) and 3 other predicates after a 121-day review. Its family tree reaches back 5 generations to 1996. 15 later devices descend from it. It has been recalled once.
- Decided
- Dec 14, 2006
- Review
- 121 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K950035 (1996). 13 ancestors in all, the oldest K912453 (1991). 15 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 4 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 3 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 2 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 1 generation backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- This deviceK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006
- Descendant · cites it directly · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- Descendant · 2 generations on · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- Descendant · 3 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · 2 generations on · 2 of its ownK180825 Fluent Fluid Management SystemHologic, Inc. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · cites it directly14descendants
- K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · 2 generations on6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 3 generations on4descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · 2 generations on2descendants
- K180825Fluent Fluid Management SystemHologic, Inc. · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −4 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −3 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −2 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −1 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| 0 (this device) | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | — |
| +1 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| +2 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
| +3 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +2 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +2 | K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K030402 | Arthroscopy Pump, Model A107Summary page 1…assification Arthroscope, 21 C.F.R. 888.1 100 Name: Regulatory Class: II Product Code: HRX Predicate Devices: 1. Arthroscopy Pump A107 (K030402) 2. Arthro-Surgiimat-A103 (K000153) 3. Arthro-Surgimat-1500 (K983910)… | 2003 |
| * | K000153 | Arthro-Surgimat-A103Summary page 1…gulatory Class: II Product Code: HRX Predicate Devices: 1. Arthroscopy Pump A107 (K030402) 2. Arthro-Surgiimat-A103 (K000153) 3. Arthro-Surgimat-1500 (K983910) 4. Lap-Wave 3000 (K990732) Device Des… | 2000 |
| * | K983910 | Arthro-Surgimat-1500Summary page 1…Devices: 1. Arthroscopy Pump A107 (K030402) 2. Arthro-Surgiimat-A103 (K000153) 3. Arthro-Surgimat-1500 (K983910) 4. Lap-Wave 3000 (K990732) Device Description: The FLOSIMPLE Arthroscopy Pump A120 (the "A120")… | 1998 |
| * | K990732 | Lap-Wave 3000 (P07)Summary page 1…2. Arthro-Surgiimat-A103 (K000153) 3. Arthro-Surgimat-1500 (K983910) 4. Lap-Wave 3000 (K990732) Device Description: The FLOSIMPLE Arthroscopy Pump A120 (the "A120") is a microprocessor controlled s… | 1999 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112642 | Aquilex Fluid Control System H112 | 2012 | 14 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2024 | Class II | Z-2243-2024 | Process control | Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K112642 (W.O.M. World of Medicine AG, 2012) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K030402.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 FLOSIMPLE Arthroscopy Pump A120 is intended to provide fluid distension
and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities
during diagnostic and operative arthroscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062380: Flosimple Arthroscopy Pump A120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062380
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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