510(k) · Cleared
ClearedArthoscopy Pump A115
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 Jan 15, 2004 as substantially equivalent to K030402 (W.O.M. World of Medicine AG, 2003) and 2 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- Jan 15, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K950035 (1996). 10 ancestors in all, the oldest K912453 (1991). 3 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 deviceK033927 Arthoscopy Pump A115W.O.M. World of Medicine AG · 2004
- Descendant · cites it directly · 2 of its ownK050580 Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK051326 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK171794 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005 · cites it directly2descendants
- K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · 2 generations on1descendant
- K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017 · 3 generations on0descendants
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) | K033927 | Arthoscopy Pump A115 | W.O.M. World of Medicine AG | 2004 | — |
| +1 | K050580 | Smith & Nephew Intelijet Fluid Management Systems | Smith & Nephew Endoscopy, Inc. | 2005 | — |
| +2 | K051326 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2005 | 6 |
| +3 | K171794 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2017 | 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? (3)
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 2…uivalence: The Arthroscopy Pump Al115 described in this notification is similar in design and technological characteristics to the Arthroscopy Pump Al 07 (K030402), to the Arthro-Surgimat-20 0 0 ECU (K990443) and Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. WORLD OF ME… | 2003 |
| * | K990443 | Arthro-Surgimat-2000 EcuSummary page 1…Predicate Devices: *Arthroscopy Pump A107 (KO30402) manufactured by W.O.M. WORLD OF MEDICINE AG *Arthro-Surgimat- 2000 ECU (K990443) manufactured by W.O.M. WORLD OF MEDICINE AG *Arthro-Surgimat-150 0 (K9839 10) manufactured by W.O.M… | 1999 |
| * | K983910 | Arthro-Surgimat-1500Summary page 1…OF MEDICINE AG *Arthro-Surgimat- 2000 ECU (K990443) manufactured by W.O.M. WORLD OF MEDICINE AG *Arthro-Surgimat-150 0 (K9839 10) manufactured by W.O.M. WORLD OF MEDICINE AG 510(K) SUMMARY Page -2- / -2- V. Intended Use:… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050580 | Smith & Nephew Intelijet Fluid Management Systems | 2005 | 2 |
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 8 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K050580 (Smith & Nephew Endoscopy, Inc., 2005) has gone furthest, with 2 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 Arthroscopy Pump Al 15 is intended to provide fluid distention and irrigation of 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/K033927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033927: Arthoscopy Pump A115.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033927
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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