# K964879: Pneumatic Arthroscopy Pulsed Irrigator System Model 0027030 and Battery Arthroscopy Pulsed Irrigator System

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: Mar 4, 1997 after 89 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830386 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830386: Davol Surgical Suction Irrigation Instr, C.R. Bard, Inc. (1983) Summary page 1.
- K942886: Simpulse Solo Suction Irrigator, Davol Inc., Sub. C. R. Bard, Inc. (1994) Summary page 1.
- K894990: Davol Arthroscopy Cannula, Davol, Inc. (1989) Summary page 1.
- (no number) Acufex Microsurgical Rasp: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K964879
Methodology: https://510kreport.com/methodology