510(k) · Cleared

Cleared

Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing

K151932510(k) TraditionalCleared Mar 31, 2016261-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

Cleared on Mar 31, 2016 as substantially equivalent to K024291 (Arthrex, Inc., 2003) after a 261-day review. Its family tree reaches back 1 generation to 2003.

Decided: Mar 31, 2016
Review: 261 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K024291 (2003). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK024291 Arthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475Arthrex, Inc. · 2003
This deviceK151932 Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use…Stryker Corporation · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K024291	Arthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475	Arthrex, Inc.	2003	—
0 (this device)	K151932	Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing	Stryker Corporation	2016	—

FIG. 1 — Lineage of K151932, 2003–2016Source: 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
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K024291	Arthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475 Summary page 4 …Arthrex Continuous Wave III Arthroscopy Pump (Tubing Only) Common Name Pump Premarket Notification K024291 Classification Name Arthroscope Regulation Number 21 CFR 888.1100 Product Code…	Arthrex, Inc.	2003	—
†	K123441	Stryker Crossflow Arthroscopy Pump	Stryker Endoscopy	2013	—

Also cleared against K024291: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K024291.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing are used in conjunction with the CrossFlow Integrated Arthroscopy Pump (K123441) to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle, and wrist joint cavities during diagnostic and operative arthroscopic procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151932 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151932: Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151932

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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