510(k) · Cleared

Cleared

Karl Storz Arthropump Power Irrigation/Suction Pump

K093471510(k) TraditionalCleared Oct 18, 2010346-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

KARL STORZ Endoscopy-America, Inc. · HRX Arthroscope

Cleared on Oct 18, 2010 as substantially equivalent to K954465 (Future Medical Systems, Inc., 1995) and 1 other predicate after a 346-day review. Its family tree reaches back 1 generation to 1995.

Decided: Oct 18, 2010
Review: 346 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K954465 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK954465 FMS DuoFuture Medical Systems, Inc. · 1995 · Recalled
This deviceK093471 Karl Storz Arthropump Power Irrigation/Suction PumpKARL STORZ Endoscopy-America, Inc. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954465	FMS Duo	Future Medical Systems, Inc.	1995	2
0 (this device)	K093471	Karl Storz Arthropump Power Irrigation/Suction Pump	KARL STORZ Endoscopy-America, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K093471, 1995–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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
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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K954465	FMS Duo Summary page 1 …r: 21 CFR 884.1730 Product Code: HRX Predicate Device(s): Future Medical Systems, Inc.: EMVS Duo (K954465) Karl Storz: Arthropump Plus (K971 649) Device Description: The Karl Storz ARTHROPU…	Future Medical Systems, Inc.	1995	2
*	K971649	Ksea Arthropump Plus Summary page 1 …ode: HRX Predicate Device(s): Future Medical Systems, Inc.: EMVS Duo (K954465) Karl Storz: Arthropump Plus (K971 649) Device Description: The Karl Storz ARTHROPUMP POWER is a combined irrigation and suction pump for…	KARL STORZ Endoscopy-America, Inc.	1997	—

Also cleared against K954465: 11 other devices →

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?

1 of the 2 ancestors has a recall of any class.
11 other devices also cite its predicate K954465.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

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

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

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 Karl Storz ARTHROPUIMP POWER Irrigation/Suction Pump is intended for use by qualified surgeons to provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures in the joints of the shoulder, knees, ankle, elbow, wrist, and hip.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093471 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093471: Karl Storz Arthropump Power Irrigation/Suction Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093471

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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