# K953269: Safecircuit Manifold/Pulmonary Unit

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Warming Systems, Inc.
- Decided: Dec 20, 1996 after 526 days
- Product code: CBN (Apparatus, Gas-Scavenging)
- Device class: 2
- Regulation: 21 CFR 868.5430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ohmeda Waste Gas Scavenging interface: named in the summary without a submission number
- (no number) North American Drager Waste Gas Scavenging interface: named in the summary without a submission number
- (no number) Dryden SONRA: named in the summary without a submission number
- (no number) Gibeck-Dryden CO₂ absorber: named in the summary without a submission number
- (no number) Ohmeda CO₂ absorber: named in the summary without a submission number

## Most influential descendants
- K123176: Iso-Gard Clearair Mask (2013), 2 descendants of its own
- K132729: Iso-Gard Mask (2014), 1 descendant of its own
- K142138: Iso-Gard Mask (2014), 0 descendants of its own

## Indications for use
The SafeCircuit Manifold/Pulmonary Unit, is intended to be used to scavenging of waste anesthetic gases from patients recovery for general anesthesia and provide supplemental oxygen. When used with the SafeCircuit Adhesive mask and a standard breathing circuit, the unit helps to reduce the amount of anesthetic agents and airborne contaminants released to the work environment of the healthcare worker.

Source page: https://510kreport.com/device/K953269
Methodology: https://510kreport.com/methodology