510(k) · Cleared

Cleared

Pneumatic Arthroscopy Pulsed Irrigator System Model 0027030 and Battery Arthroscopy Pulsed Irrigator System

K964879510(k) TraditionalCleared Mar 4, 199789-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

Davol Inc., Sub. C. R. Bard, Inc. · HRX Arthroscope

Cleared on Mar 4, 1997 as substantially equivalent to K830386 (C.R. Bard, Inc., 1983) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1983.

Decided: Mar 4, 1997
Review: 89 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K830386 (1983). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK830386 Davol Surgical Suction Irrigation InstrC.R. Bard, Inc. · 1983
This deviceK964879 Pneumatic Arthroscopy Pulsed Irrigator System Model 0027030 and…Davol Inc., Sub. C. R. Bard, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K830386	Davol Surgical Suction Irrigation Instr	C.R. Bard, Inc.	1983	—
0 (this device)	K964879	Pneumatic Arthroscopy Pulsed Irrigator System Model 0027030 and Battery…	Davol Inc., Sub. C. R. Bard, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1994	1	0

FIG. 1 — Lineage of K964879, 1983–1997Source: 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
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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K830386	Davol Surgical Suction Irrigation Instr Summary page 1 …sification Name: Jet Lavage, General Hospital Use Devices & Arthroscopes and Accessories, Orthopedic Devices Predicate Device: - Davol Simpulse Plus Suction Irrigator (K830386) - Davol Simpulse SOLO Suction Irrigator (K942886) - Arthroscopy Outflow Cannula (K894990) - Femoral Canal Irrigation Brush Ti…	C.R. Bard, Inc.	1983	—
*	K942886	Simpulse Solo Suction Irrigator Summary page 1 …evices & Arthroscopes and Accessories, Orthopedic Devices Predicate Device: - Davol Simpulse Plus Suction Irrigator (K830386) - Davol Simpulse SOLO Suction Irrigator (K942886) - Arthroscopy Outflow Cannula (K894990) - Femoral Canal Irrigation Brush Tip (K830386 & K942886) - Microsurgical Rasp The Pn…	Davol Inc., Sub. C. R. Bard, Inc.	1994	—
*	K894990	Davol Arthroscopy Cannula Summary page 1 …thopedic Devices Predicate Device: - Davol Simpulse Plus Suction Irrigator (K830386) - Davol Simpulse SOLO Suction Irrigator (K942886) - Arthroscopy Outflow Cannula (K894990) - Femoral Canal Irrigation Brush Tip (K830386 & K942886) - Microsurgical Rasp The Pneumatic Arthroscopy Pulsed Irrigator (API…	Davol, Inc.	1989	—
*	—	Acufex Microsurgical Rasp Named without a submission number			—

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?

None of the 3 ancestors has a recall.

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

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?

Both the Pneumatic API system and the Battery API system are designed to provide controlled pulsatile irrigation to a joint during arthroscopic surgical procedures. The pulsatile action of the pump irrigation and mechanical debridement of tip brush help to remove blood, tissue debris, loose bodies, and foreign matter from the joint cavity. When connected to a suction source the device’s can be used to aspirate fluids and debris from the joint cavity.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964879 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964879: Pneumatic Arthroscopy Pulsed Irrigator System Model 0027030 and Battery Arthroscopy Pulsed Irrigator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964879

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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