# K961318: 1ST Response Disposable Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Intertech Resources, Inc.
- Decided: Dec 17, 1996 after 256 days
- Product code: CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm))
- Device class: 2
- Regulation: 21 CFR 868.2600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K092687: Venti.Plus Hyperinflation Bag System with Pressure Manometer (2009), 1 descendant of its own
- K102377: Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O; Ventiplus Disposable Manometer 0 (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K961318
Methodology: https://510kreport.com/methodology