510(k) · Cleared

Cleared

Spiritus (TM) Respiratory System #SRS 001

K020641510(k) TraditionalCleared Oct 29, 2002244-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Worldwide Medical Technologies, LLC · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Oct 29, 2002 as substantially equivalent to K900164 (Puritan Bennett Corp., 1990) after a 244-day review. Its family tree reaches back 1 generation to 1990. 10 later devices descend from it.

Decided: Oct 29, 2002
Review: 244 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K900164 (1990). 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK900164 Airway Delivery & Management (Adam) Nasal Ventila.Puritan Bennett Corp. · 1990
This deviceK020641 Spiritus (TM) Respiratory System #SRS 001Worldwide Medical Technologies, LLC · 2002
Descendant · cites it directly · 9 of its ownK033759 C2 Nasal MaskRespironics, Inc. · 2004
Descendant · 2 generations on · 8 of its ownK042130 Aura Cpap Patient InterfaceAeiomed, Inc. · 2004
Descendant · 3 generations on · 5 of its ownK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
Descendant · 4 generations on · 1 of its ownK132127 Transcend AutoSomnetics International, Inc. · 2013
Descendant · 4 generations on · 1 of its ownK121374 ZI BlowerDeshum Medical · 2013

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2004high 2 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all

K033759C2 Nasal MaskRespironics, Inc. · 2004 · cites it directly9descendants
K042130Aura Cpap Patient InterfaceAeiomed, Inc. · 2004 · 2 generations on8descendants
K100121Model 300157 Cpap SystemAeiomed, Inc. · 2010 · 3 generations on5descendants
K132127Transcend AutoSomnetics International, Inc. · 2013 · 4 generations on1descendant
K121374ZI BlowerDeshum Medical · 2013 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900164	Airway Delivery & Management (Adam) Nasal Ventila.	Puritan Bennett Corp.	1990	—
0 (this device)	K020641	Spiritus (TM) Respiratory System #SRS 001	Worldwide Medical Technologies, LLC	2002	—
+1	K033759	C2 Nasal Mask	Respironics, Inc.	2004	—
+2	K042130	Aura Cpap Patient Interface	Aeiomed, Inc.	2004	—
+3	K100121	Model 300157 Cpap System	Aeiomed, Inc.	2010	—
+4	K132127	Transcend Auto	Somnetics International, Inc.	2013	—
+4	K121374	ZI Blower	Deshum Medical	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2008	1	0
2009	1	0
2010	1	0
2013	2	0
2014	1	0
2015	1	0
2018	1	0

FIG. 1 — Lineage of K020641, 1990–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BZD device

#1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K900164	Airway Delivery & Management (Adam) Nasal Ventila. Summary page 1 …g adult patients. 8. Predicate Device Substantial equivalence is claimed to the Puritan-Bennett Airway Delivery & Management (ADAM) Nasal Ventilation, subject of 5 10(k) K900164. 9. Summary of Performance Testing Performance was confirmed through the execution of flow resistance, enclosed volume, and inten…	Puritan Bennett Corp.	1990	—

Also cleared against K900164: 3 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033759	C2 Nasal Mask	Respironics, Inc.	2004	9

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K033759 (Respironics, Inc., 2004) has gone furthest, with 9 descendants of its own.
3 other devices also cite its predicate K900164.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	21	83	29	65
2008	17	108	2	67
2009	23	90	1	147
2010	12	122	0	143
2011	23	125	1	189
2012	21	133	0	139
2013	23	127	0	82
2014	14	172	0	86
2015	11	224	0	114
2016	12	217	0	118
2017	5	221	0	148
2018	5	280	0	101
2019	6	231	4 (4)	188
2020	6	137	0	126
2021	6	192	0	6,066
2022	4	253	0	90,768
2023	5	204	8 (7)	27,987
2024	10	132	0	68,262
2025	7	189	0	60,279
2026	10	214	2 (2)	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020641 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020641: Spiritus (TM) Respiratory System #SRS 001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020641

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026