510(k) · Cleared

Cleared

Millennium Infant Ventilator

K993167510(k) SpecialCleared Nov 10, 199949-day reviewClass II21 CFR 868.5895

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

Sechrist Industries, Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on Nov 10, 1999 as substantially equivalent to K833982 (Sechrist Industries, Inc., 1984) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided: Nov 10, 1999
Review: 49 days
Class: Class II
Product code: CBK
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K833982 (1984). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK833982 Model IV 100B-DA Infant VentilatorSechrist Industries, Inc. · 1984 · Recalled
This deviceK993167 Millennium Infant VentilatorSechrist Industries, Inc. · 1999
Descendant · cites it directly · 0 of its ownK121379 Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv)…Airon Corporation · 2012

Most influential descendants

Showing 1 of 1 · See all

K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K833982	Model IV 100B-DA Infant Ventilator	Sechrist Industries, Inc.	1984	1
0 (this device)	K993167	Millennium Infant Ventilator	Sechrist Industries, Inc.	1999	—
+1	K121379	Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit…	Airon Corporation	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K993167, 1984–2012Source: 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.

Planning a device in CBK? 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 CBK device

#1 K252663 Inbentus Versatilescore 16.0 · 17 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? (3)

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
*	K833982	Model IV 100B-DA Infant Ventilator Summary page 1 …Name: Classification Name: Continuous ventilator Common Name: Infant ventilator Proprietary Name: Millennium Devices to which Equivalence is Claimed: =~ Model IV-100B K833982A V.LP. Bird Infant Ventilator K895541/K901885 Contact: Greg Godfrey, Vice President Quality Assurance & Regulatory Affairs 4225…	Sechrist Industries, Inc.	1984	1
*	K895541	V.I.P. Bird Infant - Pediatric Ventilator Summary page 1 …s ventilator Common Name: Infant ventilator Proprietary Name: Millennium Devices to which Equivalence is Claimed: =~ Model IV-100B K833982A V.LP. Bird Infant Ventilator K895541/K901885 Contact: Greg Godfrey, Vice President Quality Assurance & Regulatory Affairs 4225 E. La Palma Avenue Anaheim, CA 92807 P…	Bird Products Corp.	1990	—
*	K901885	Partner Volume Monitor Summary page 1 …ator Common Name: Infant ventilator Proprietary Name: Millennium Devices to which Equivalence is Claimed: =~ Model IV-100B K833982A V.LP. Bird Infant Ventilator K895541/K901885 Contact: Greg Godfrey, Vice President Quality Assurance & Regulatory Affairs 4225 E. La Palma Avenue Anaheim, CA 92807 Phone: (7…	Bird Products Corp.	1990	—

Also cleared against K833982: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K121379	Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory	Airon Corporation	2012	0

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K121379 (Airon Corporation, 2012) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K833982.

How does its category compare?

All CBK devices

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBK

4in 2025

2007high 18 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBK

163in 2025

2007high 439 (2014) · low 115 (2008)2026

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

Recalls per year · CBK

14in 2024

2007high 23 (2008) · low 0 (2025)2026

Class I (81 since 2007) Class II/III not classified

Adverse event reports per year · CBK

13,991in 2025

2007high 24,928 (2023) · low 1,531 (2007)2025

MAUDE reports naming product code CBK, 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	11	142	17	1,531
2008	18	115	23	1,933
2009	12	122	8	1,766
2010	14	150	9	1,799
2011	13	192	12	1,877
2012	17	207	2 (1)	5,509
2013	5	277	5 (2)	7,921
2014	5	439	5 (4)	7,600
2015	7	266	6 (4)	11,876
2016	4	323	4 (1)	16,056
2017	6	280	1	14,451
2018	4	183	3 (3)	9,849
2019	8	435	14 (13)	9,100
2020	5	176	4	11,096
2021	6	267	21 (19)	13,322
2022	0	—	8 (4)	15,974
2023	5	309	4 (3)	24,928
2024	9	203	14 (14)	20,336
2025	4	163	0	13,991
2026	3	235	15 (13)	—

What is it indicated for?

The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993167 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993167: Millennium Infant Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993167

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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