# K963481: Anodyne CC

- Pathway: 510(k) (Traditional)
- Applicant: Heyer America, Inc.
- Decided: Aug 11, 1997 after 342 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- 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 K882489 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882489: Revised Pneumatic Diagrams for Modulus II Plus, Ohmeda Medical (1988). Our OCR of the scanned summary read K882484, FDA’s number for CMS Record and Verify System (Computerized Medical Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Modulus II Plus Ohmeda”. Summary page 2.
- K930351: Narkomed 2C Anesthesia System, Draeger Medical, Inc. (1993) Summary page 1.

## Indications for use
The AnodyneTM CC-Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient’s ventilation.

Source page: https://510kreport.com/device/K963481
Methodology: https://510kreport.com/methodology