510(k) · Cleared

Recalled · 2005

Guardian Neonate Cpap/Humidification System

K040862510(k) TraditionalCleared Jun 30, 200489-day reviewClass II21 CFR 868.5905Recalls 2

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

Caradyne, Ltd. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jun 30, 2004 as substantially equivalent to K011516 (Eme (Electro Medical Equipment), Ltd., 2001) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it. It has been recalled 2 times.

Decided: Jun 30, 2004
Review: 89 days
Class: Class II
Product code: BZD
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K000401 (2000). 2 ancestors in all. 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK000401 Vapotherm, Model 2000IVapotherm, Inc. · 2000
This deviceK040862 Guardian Neonate Cpap/Humidification SystemCaradyne, Ltd. · 2004
Descendant · cites it directly · 6 of its ownK042245 Vapotherm Model#2000I, 200HVapotherm, Inc. · 2004
Descendant · 2 generations on · 2 of its ownK072845 Precision FlowVapotherm, Inc. · 2008 · Recalled
Descendant · 3 generations on · 0 of its ownK254078 HVT 2.0Vapotherm, Inc. · 2026
Descendant · 2 generations on · 0 of its ownK193411 O2asis Personal Oxygen HumidifierPerma Pure, LLC · 2020
Descendant · 3 generations on · 0 of its ownK111640 Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004high 2 (2007) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all

K042245Vapotherm Model#2000I, 200HVapotherm, Inc. · 2004 · cites it directly6descendants
K072845Precision FlowVapotherm, Inc. · 2008 · 2 generations on2descendants
K254078HVT 2.0Vapotherm, Inc. · 2026 · 3 generations on0descendants
K193411O2asis Personal Oxygen HumidifierPerma Pure, LLC · 2020 · 2 generations on0descendants
K111640Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000401	Vapotherm, Model 2000I	Vapotherm, Inc.	2000	—
0 (this device)	K040862	Guardian Neonate Cpap/Humidification System	Caradyne, Ltd.	2004	—
+1	K042245	Vapotherm Model#2000I, 200H	Vapotherm, Inc.	2004	—
+2	K072845	Precision Flow	Vapotherm, Inc.	2008	8
+3	K254078	HVT 2.0	Vapotherm, Inc.	2026	—
+2	K193411	O2asis Personal Oxygen Humidifier	Perma Pure, LLC	2020	—
+3	K111640	Precision Flow (R) - Heliox	Vapotherm, Inc.	2011	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	2	0
2008	1	0
2011	2	0
2020	1	0
2026	1	0

FIG. 1 — Lineage of K040862, 2000–2026Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K011516	Infant Flow System, Model M672P Summary page 1 …CPAP system Classification Name; Ventilator, non-continuous (Respirator) Predicate Devices: EME - Infant Flow systems - K01 1516 Vapothern -20001 - K000401 ]Device Description The Guardian Neonate CPAP / Humidificatio…	Eme (Electro Medical Equipment), Ltd.	2001	—
*	K000401	Vapotherm, Model 2000I Summary page 1 …Ventilator, non-continuous (Respirator) Predicate Devices: EME - Infant Flow systems - K01 1516 Vapothern -20001 - K000401 ]Device Description The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonat…	Vapotherm, Inc.	2000	—

Also cleared against K011516: 2 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042245	Vapotherm Model#2000I, 200H	Vapotherm, Inc.	2004	6
K103410	Neopap System	Childrens Medical Ventures, LLC	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 27, 2005	Not classified	Z-0717-06	Other	Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.
Sep 19, 2005	Not classified	Z-1191-06	Other	Gas input pressures over 62 psi may cause CPAP pressure oscillation

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K042245 (Vapotherm, Inc., 2004) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K011516.

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?

Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS. (Respiratory Distress Syndrome) May or may not include humidification capabilities

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040862 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040862: Guardian Neonate Cpap/Humidification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040862

Report an extraction error

Are you the manufacturer?

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