510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

FMS Duo

K954465510(k) TraditionalCleared Nov 9, 199545-day reviewClass II21 CFR 888.1100Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Future Medical Systems, Inc. · HRX Arthroscope

Cleared on Nov 9, 1995 after a 45-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 46 later devices descend from it. It has been recalled 2 times.

Decided
Nov 9, 1995
Review
45 days
Class
Class II
Product code
HRX
Recalls
2
Predicates
0

46 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2013: 6 descendants cleared2005: 3 descendants cleared2003: 1 descendant cleared2009: 1 descendant cleared2016: 1 descendant cleared2010: 2 descendants cleared2008: 1 descendant cleared2007: 1 descendant cleared2006: 2 descendants cleared2004: 1 descendant cleared2018: 7 descendants cleared2020: 2 descendants cleared2024: 4 descendants cleared2012: 1 descendant cleared2025: 1 descendant cleared2019: 4 descendants cleared2017: 2 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared2026: 1 descendant cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954465 FMS DuoFuture Medical Systems, Inc. · 1995
  2. Descendant · cites it directly · 29 of its ownK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
  3. Descendant · 2 generations on · 15 of its ownK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
  4. Descendant · 3 generations on · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
  5. Descendant · 4 generations on · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
  6. Descendant · cites it directly · 6 of its ownK041824 X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA · 2005 · Recalled

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 32006: 22007: 12008: 12009: 12010: 22012: 12013: 62016: 12017: 22018: 72019: 42020: 22021: 12022: 12023: 32024: 42025: 12026: 1
2003high 7 (2018) · low 0 (2011)2026

Most influential descendants

Showing 5 of 46 · See all
  • K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003 · cites it directly29descendants
  • K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · 2 generations on15descendants
  • K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · 3 generations on14descendants
  • K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · 4 generations on6descendants
  • K041824X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA · 2005 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954465FMS DuoFuture Medical Systems, Inc.1995—
+1K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG2003—
+2K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG20061
+3K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG2012—
+4K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG2013—
+1K041824X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA20052

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200530
200620
200710
200810
200910
201020
201210
201360
201610
201720
201870
201940
202020
202110
202210
202330
202440
202510
202610
FIG. 1 — Lineage of K954465, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (46)

See all 46

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG200329
K041824X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA20056
K130169FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company20135
K083707Arthrex Dual Wave Arthroscopy Fluid Management DeviceArthrex, Inc.20093
K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec20071
K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam20160
K132883Hemodia Arthroscopy Pump Tube Sets (Hats)Hemodia Sas20130
K1311914MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus…Depuy Mitek, A Johnson & Johnson Company20130
K130912Omnicut Resection BladeDepuy Mitek, A Johnson & Johnson Company20130
K093471Karl Storz Arthropump Power Irrigation/Suction PumpKARL STORZ Endoscopy-America, Inc.20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 20, 2015Class IIZ-0658-2016Process controlProduct is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Aug 29, 2013Class IIZ-0192-2014Component change controlPillow 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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030402 (W.O.M. World of Medicine AG, 2003) has gone furthest, with 29 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

More from Future Medical Systems, Inc.

12 FDA decisions under this applicant name. See the company

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  • K021030Titanium Cannulated Interference ScrewFuture Medical Systems, Inc. · 2002
  • K013685Plla Cannulated Interference ScrewFuture Medical Systems, Inc. · 2002
  • K002040FMS SoloFuture Medical Systems, Inc. · 20001 recall
  • K980808Endo FMS UrologyFuture Medical Systems, Inc. · 1998

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https://510kreport.com/device/K954465 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954465: FMS Duo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954465

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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