510(k) · Cleared
ClearedConcept Universal Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HIG Insufflator, Hysteroscopic
Cleared on Dec 29, 1994 after a 507-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 37 later devices descend from it.
- Decided
- Dec 29, 1994
- Review
- 507 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 4 citing it directly.
- This deviceK933873 Concept Universal Pump SystemLinvatec Corp. · 1994
- Descendant · cites it directly · 32 of its ownK962114 Arthro-SurgimatW.O.M. World of Medicine GmbH · 1996
- Descendant · 2 generations on · 31 of its ownK983910 Arthro-Surgimat-1500W.O.M. World of Medicine GmbH · 1998
- Descendant · cites it directly · 30 of its ownK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- Descendant · 2 generations on · 29 of its ownK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- Descendant · 3 generations on · 15 of its ownK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K962114Arthro-SurgimatW.O.M. World of Medicine GmbH · 1996 · cites it directly32descendants
- K983910Arthro-Surgimat-1500W.O.M. World of Medicine GmbH · 1998 · 2 generations on31descendants
- K990443Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999 · cites it directly30descendants
- K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003 · 2 generations on29descendants
- K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933873 | Concept Universal Pump System | Linvatec Corp. | 1994 | — |
| +1 | K962114 | Arthro-Surgimat | W.O.M. World of Medicine GmbH | 1996 | — |
| +2 | K983910 | Arthro-Surgimat-1500 | W.O.M. World of Medicine GmbH | 1998 | — |
| +1 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| +2 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| +3 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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.
Planning a device in HIG? 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 HIG device
- #1 K261706 Endomat Select (UP220)score 14.1 · 9 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (37)
See all 374 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K962114 (W.O.M. World of Medicine GmbH, 1996) has gone furthest, with 32 descendants of its own.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIG
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIG
45in 2025
MAUDE reports naming product code HIG, 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 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 4 | 175 | 0 | 10 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 130 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 0 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K933873 · printed Nov 5, 2026
Cite this page
510(k) Report. “K933873: Concept Universal Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933873
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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