# K030985: Breas PV 10I Cpap System, Model PV 10I

- Pathway: 510(k) (Traditional)
- Applicant: Vital Signs, Inc.
- Decided: Oct 15, 2003 after 201 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: 5 generations back to K903764 (1990). 13 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001553: Breas PV 100 Cpap System, Vital Signs, Inc. (2000)
- K970516: Sullivan Autoset Home Nasal Cpap System, Resmed, Ltd. (1997) Summary page 1.
- K970771: Sullivan Autoset Portable II Nasal Cpap System, Resmed, Ltd. (1997) Summary page 1.
- K984428: Sullivan Autoset Nasal Cpap System, Resmed, Ltd. (1999) Summary page 1.
- K980721: Sullivan Autoset, Resmed, Ltd. (1998) Summary page 5.
- K993584: Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2, Nellcor Puritan Bennett France Dvpt. (2000) Summary page 5.

## Most influential descendants
- K063476: Breas Isleep 20I (2007), 12 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K042945: Aura Cpap System (2005), 6 descendants of its own
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own
- K100121: Model 300157 Cpap System (2010), 5 descendants of its own

## Indications for use
The Breas PV 1Oi CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

Source page: https://510kreport.com/device/K030985
Methodology: https://510kreport.com/methodology