510(k) Report

510(k) · Cleared

Cleared

Hemodia Arthroscopy Pump Tube Sets (Hats)

K132883510(k) TraditionalCleared Nov 1, 201349-day reviewClass II21 CFR 888.1100

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

Hemodia Sas · HRX Arthroscope

Cleared on Nov 1, 2013 as substantially equivalent to K925160 (Orthoconcept, Inc., 1994) and 3 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1994.

Decided
Nov 1, 2013
Review
49 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K925160 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1995: 2 other ancestorsK925160 · Arthro FMS 4 · Orthoconcept, Inc. · 1994199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors K925160 · Arthro FMS 4 · Orthoconcept, Inc. · 19940
  1. Root · 1 generation backK925160 Arthro FMS 4Orthoconcept, Inc. · 1994
  2. This deviceK132883 Hemodia Arthroscopy Pump Tube Sets (Hats)Hemodia Sas · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K925160Arthro FMS 4Orthoconcept, Inc.1994—
0 (this device)K132883Hemodia Arthroscopy Pump Tube Sets (Hats)Hemodia Sas2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
200010
FIG. 1 — Lineage of K132883, 1994–2013Source: 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), 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K925160Arthro FMS 4
Summary page 1
…thopedic __________________Product Code: HRX Equivalent Device(s): * OrthoConcept (FMS 4+ & disposables) K925160 * FMS K954465 (FMS DUO®0 + & disposables)…
Orthoconcept, Inc.1994—
*K954465FMS Duo
Summary page 1
…Code: HRX Equivalent Device(s): * OrthoConcept (FMS 4+ & disposables) K925160 * FMS K954465 (FMS DUO®0 + & disposables) * FMS K951843 (REF. 4102CV INTERMEDIARY…
Future Medical Systems, Inc.19952
*K951843Ref. 4102CV Intermediary Tubing, Ref. 4509CV Sterile Zone Kit
Summary page 1
…sables) K925160 * FMS K954465 (FMS DUO®0 + & disposables) * FMS K951843 (REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT)…
Future Medical Systems, Inc.19953
*K002040FMS Solo
Summary page 1
…4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT) * FMS K002040 (FMS SOLO® & disposables) Device Description: HEMODIA ARTHROSCOPY PUMP TUBE SETS…
Future Medical Systems, Inc.20001

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 3 of the 4 ancestors have a recall of any class.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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—

What is it indicated for?

The device intended to be used in conjunction with the FMS/Depuy/Mitek arthroscopic pump systems and delivers irrigation fluid both to and from the pump and to and from the operative site during arthroscopic procedures.

Indications for use as stated in the FDA summary.

More from Hemodia Sas

4 FDA decisions under this applicant name. See the company

  • K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas · 2023
  • K203480DOUBLEFLO systemHemodia Sas · 2021
  • K192921Zeos Aqua Vision Pump and tubeHemodia Sas · 2020

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
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https://510kreport.com/device/K132883 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132883: Hemodia Arthroscopy Pump Tube Sets (Hats).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132883

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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