510(k) · Cleared

Cleared

AV-S Anaesthesia Ventilator

K051222510(k) TraditionalCleared Sep 23, 2005134-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

Penlon Limited · CBK Ventilator, Continuous, Facility Use

Cleared on Sep 23, 2005 as substantially equivalent to K010317 (Penlon, Ltd., 2001) and 3 other predicates after a 134-day review. Its family tree reaches back 2 generations to 1994. 1 of the 8 devices in its family, counting itself, has a Class I recall.

Decided: Sep 23, 2005
Review: 134 days
Class: Class II
Product code: CBK
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K930017 (1994). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
1 generation backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
This deviceK051222 AV-S Anaesthesia VentilatorPenlon Limited · 2005

Class I recalls in this family

K023366 Datex-Ohmeda 7900 Ventilator Enhancementsdirect predicate · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K930017	PB 7200 Series Ventilatory System W/Keyboard	Puritan Bennett Corp.	1994	—
−1	K023366	Datex-Ohmeda 7900 Ventilator Enhancements	Datex-Ohmeda, Inc.	2003	Class I
0 (this device)	K051222	AV-S Anaesthesia Ventilator	Penlon Limited	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
2001	2	0

FIG. 1 — Lineage of K051222, 1994–2005Source: 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 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? (4)

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
*	K010317	AV 800 Ventilator Summary page 1 …arketed predicate devices to which substantial equivalence is claimed: 1. Penlon Limited AV800 Anaesthesia Ventilator - FDA 510(k) No. K010317 approved by FDA on July 23, 2001. FDA Device Classification: Class II FDA Classification Number: 21…	Penlon, Ltd.	2001	—
*	K010318	Prima Oxygen Monitor Summary page 1 …I FDA Classification Number: 21CFR 868.5895 FDA Classification Code: CBK 2. Penlon Limited Prima Oxygen Monitor - FDA 510(k) No. K010318 approved by FDA on July 23, 2001 FDA Device Classification: Class 1I FDA Classific…	Penlon, Ltd.	2001	—
*	K960964	Ohmeda 7900 Anesthesia Ventilator Summary page 1 …ication Number: 21 CFR 868.1720 FDA Classification Code: CCL 3. Datex-Ohmeda Inc. 7900 Anaesthesia Ventilator - FDA 510(k) No. K960964 approved by FDA on September 27, 1996, and K023366 approved by FDA on October 7, 2003 FDA Device…	Ohmeda Medical	1996	—
*	K023366	Datex-Ohmeda 7900 Ventilator Enhancements Summary page 1 …Classification Code: CCL 3. Datex-Ohmeda Inc. 7900 Anaesthesia Ventilator - FDA 510(k) No. K960964 approved by FDA on September 27, 1996, and K023366 approved by FDA on October 7, 2003 FDA Device Classification: Class 11 FDA Classi…	Datex-Ohmeda, Inc.	2003	Class I

What descends from it?

No later submission names this one as a predicate yet.

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.

K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.

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 AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. Specifically the ventilator is indicated for use by both adult and pediatric patients.

The AV-S Anaesthesia ventilator is a prescription device and the labelling indicates this.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051222 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051222: AV-S Anaesthesia Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051222

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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