# K953550: CO2 Arthroflator

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Aug 23, 1995 after 26 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The KSEA Model 284120 20 CO₂ Arthroflator is designed to facilitate the use of arthroscopes by distending the space surrounding a joint with CO₂ gas during arthroscopic surgical and diagnostic procedures.

Source page: https://510kreport.com/device/K953550
Methodology: https://510kreport.com/methodology