# K020641: Spiritus (TM) Respiratory System #SRS 001

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical Technologies, LLC
- Decided: Oct 29, 2002 after 244 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: 1 generation back to K900164 (1990). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900164: Airway Delivery & Management (Adam) Nasal Ventila., Puritan Bennett Corp. (1990) Summary page 1.

## Most influential descendants
- K033759: C2 Nasal Mask (2004), 9 descendants of its own
- K042130: Aura Cpap Patient Interface (2004), 8 descendants of its own
- K100121: Model 300157 Cpap System (2010), 5 descendants of its own
- K132127: Transcend Auto (2013), 1 descendant of its own
- K121374: ZI Blower (2013), 1 descendant of its own

## Indications for use
The SpiritusTM Respiratory System is a single-patient-use, patient interface accessory intended for use by patients who have been prescribed positive airway pressure treatment (PAP) including CPAP and BiPAP.

Source page: https://510kreport.com/device/K020641
Methodology: https://510kreport.com/methodology