510(k) · Cleared
Recalled · Class II · 2013Ref. 4102CV Intermediary Tubing, Ref. 4509CV Sterile Zone Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Future Medical Systems, Inc. · HRX Arthroscope
Cleared on Jul 14, 1995 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 14, 1995
- Review
- 85 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK951843 Ref. 4102CV Intermediary Tubing, Ref. 4509CV Sterile Zone KitFuture Medical Systems, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK132883 Hemodia Arthroscopy Pump Tube Sets (Hats)Hemodia Sas · 2013
Most influential descendants
Showing 1 of 1 · See all- K132883Hemodia Arthroscopy Pump Tube Sets (Hats)Hemodia Sas · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951843 | Ref. 4102CV Intermediary Tubing, Ref. 4509CV Sterile Zone Kit | Future Medical Systems, Inc. | 1995 | — |
| +1 | K132883 | Hemodia Arthroscopy Pump Tube Sets (Hats) | Hemodia Sas | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 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
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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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132883 | Hemodia Arthroscopy Pump Tube Sets (Hats) | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2013 | Class II | Z-0191-2014 | Component change control | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient… |
| Dec 3, 2010 | Not classified | Z-1948-2011 | Packaging process control | Product sterility may be compromised due to breach in sterile packaging |
| Dec 3, 2010 | Not classified | Z-1946-2011 | Packaging process control | Product sterility may be compromised due to breach in sterile packaging |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132883 (Hemodia Sas, 2013) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K951843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951843: Ref. 4102CV Intermediary Tubing, Ref. 4509CV Sterile Zone Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951843
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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