# K012034: Modification to: Sipap Infant Nasal Cpap Circuit

- Pathway: 510(k) (Special)
- Applicant: Sensor Medics Corp.
- Decided: Jul 24, 2001 after 25 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945740 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960359: Aladdin Monitoring Oxygen/Air Mixer, Hamilton Medical, Inc. (1996) Summary page 1.
- K945740: Infant Flow System, Hamilton Medical, Inc. (1995) Summary page 1.
- K974303: Infant Flow System, Sensor Medics Corp. (1998) Summary page 1.
- K984254: Infant Flow Ncpap Masks, Sensor Medics Corp. (1999) Summary page 1.
- K991972: Infant Flow System, Sensor Medics Corp. (1999) Summary page 1.

## Indications for use
The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

Source page: https://510kreport.com/device/K012034
Methodology: https://510kreport.com/methodology