510(k) · Cleared

Cleared

Babi Plus Infant Nasal Cannula System

K093716510(k) TraditionalCleared May 13, 2010162-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

A Plus Medical · BZD Ventilator, Non-Continuous (Respirator)

Cleared on May 13, 2010 as substantially equivalent to K871157 (Hudson Oxygen Therapy Sales Co., 1987) after a 162-day review. Its family tree reaches back 1 generation to 1987. 1 of the 5 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.

Decided: May 13, 2010
Review: 162 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K871157 (1987). 3 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK871157 C.P.a.P. Nasal CannulaHudson Oxygen Therapy Sales Co. · 1987 · Recalled
This deviceK093716 Babi Plus Infant Nasal Cannula SystemA Plus Medical · 2010
Descendant · cites it directly · 1 of its ownK110471 Babi Plus Infant Nasal Cannula SystemA Plus Medical · 2011
Descendant · 2 generations on · 0 of its ownK121379 Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv)…Airon Corporation · 2012
Descendant · cites it directly · 0 of its ownK110383 Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical · 2011 · Recalled (Class I)

Class I recalls in this family

K110383 Babi*Plus Pressure Relief Manifold - 10CM H20…cites it directly · 2011

Most influential descendants

Showing 3 of 3 · See all

K110471Babi Plus Infant Nasal Cannula SystemA Plus Medical · 2011 · cites it directly1descendant
K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation · 2012 · 2 generations on0descendants
K110383Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871157	C.P.a.P. Nasal Cannula	Hudson Oxygen Therapy Sales Co.	1987	5
0 (this device)	K093716	Babi Plus Infant Nasal Cannula System	A Plus Medical	2010	—
+1	K110471	Babi Plus Infant Nasal Cannula System	A Plus Medical	2011	—
+2	K121379	Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit…	Airon Corporation	2012	—
+1	K110383	Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20	A Plus Medical	2011	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	1
2012	1	0

FIG. 1 — Lineage of K093716, 1987–2012Source: 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.

1 device in this family has a Class I recall. 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
*	K871157	C.P.a.P. Nasal Cannula Summary page 1 …nuous (respirator) Product Code: BZD Regulation: 868.5905 Device Class: II Device: The Bab!i*Plus Nasal Carnula Predicate Devices: Number: K871 157 Product Name: Infant Nasal CPAP Cannula Manufacturer: Hudson Oxygen Therapy Sales Company (Telefl…	Hudson Oxygen Therapy Sales Co.	1987	5

Also cleared against K871157: 2 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K110471	Babi Plus Infant Nasal Cannula System	A Plus Medical	2011	1
K110383	Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20 Class I	A Plus Medical	2011	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K110383Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K110471 (A Plus Medical, 2011) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K871157.

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. 2010, this device’s year, is highlighted.

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?

Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093716 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093716: Babi Plus Infant Nasal Cannula System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093716

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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