510(k) · Cleared

Cleared

Vitalert 3000 Monitoring System

K913995510(k) TraditionalCleared Nov 3, 1992424-day reviewClass II21 CFR 868.1400

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

Draeger Medical, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Nov 3, 1992 after a 424-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 295 devices in its family, counting itself, have a Class I recall. 294 later devices descend from it.

Decided: Nov 3, 1992
Review: 424 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 0

294 later devices descend from it, 1 citing it directly. 2 of the 295 devices in this family, counting this one, have a Class I recall.

This deviceK913995 Vitalert 3000 Monitoring SystemDraeger Medical, Inc. · 1992
Descendant · cites it directly · 293 of its ownK012139 Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2002
Descendant · 2 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
Descendant · 2 generations on · 270 of its ownK040847 Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004
Descendant · 2 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
Descendant · 3 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 294 descendants. See all descendants

Descendants cleared per year

2002high 22 (2023) · low 1 (2002)2026

Class I recalls in this family

K133886 Perseus A5004 generations on · 2014
K230931 Atlan5 generations on · 2023

Most influential descendants

Showing 5 of 294 · See all

K012139Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2002 · cites it directly293descendants
K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on280descendants
K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004 · 2 generations on270descendants
K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 2 generations on251descendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on249descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913995	Vitalert 3000 Monitoring System	Draeger Medical, Inc.	1992	—
+1	K012139	Vamos Anesthetic Gas Monitor	Draeger Medical, Inc.	2002	—
+2	K031340	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…	Siemens Medical Solutions USA, Inc.	2003	—
+2	K040847	Modification to Vamos Anesthetic Gas Monitor	Draeger Medical, Inc.	2004	—
+2	K041956	Emg - Essential Gas Module, Model M1013A	Draeget Medical AG & Co. Kgaa	2004	—
+3	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	7	0
2005	9	0
2006	14	0
2007	7	0
2008	5	0
2009	5	0
2010	9	0
2011	11	0
2012	10	0
2013	13	0
2014	13	1
2015	12	0
2016	13	0
2017	13	0
2018	16	0
2019	11	0
2020	11	0
2021	15	0
2022	20	0
2023	22	1
2024	18	0
2025	21	0
2026	17	0

FIG. 1 — Lineage of K913995, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

2 devices in this family have 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 CCK device

#1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (294)

See all 294

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

Number	Device	Applicant	Decided	Descendants
K012139	Vamos Anesthetic Gas Monitor	Draeger Medical, Inc.	2002	293

Has anything in its family been recalled? (2 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.

K133886Perseus A500Draeger Medical GmbH · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls

What does this lineage say?

Of its descendants, K012139 (Draeger Medical, Inc., 2002) has gone furthest, with 293 descendants of its own.

How does its category compare?

All CCK devices

CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCK

3in 2025

2007high 9 (2014) · low 2 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCK

169in 2025

2007high 592 (2024) · low 56 (2007)2026

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

Recalls per year · CCK

1in 2022

2007high 19 (2009) · low 0 (2007)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · CCK

1,259in 2025

2007high 2,475 (2022) · low 7 (2007)2025

MAUDE reports naming product code CCK, 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	5	56	0	7
2008	3	248	1	20
2009	3	101	19	21
2010	3	125	4	12
2011	2	—	14	18
2012	7	150	3	13
2013	4	132	2 (1)	28
2014	9	166	0	51
2015	5	105	1	114
2016	2	—	0	88
2017	5	134	0	58
2018	6	296	5	63
2019	7	261	7 (7)	141
2020	4	188	1	2,302
2021	4	227	0	2,272
2022	3	226	1	2,475
2023	4	555	0	1,637
2024	3	592	0	1,216
2025	3	169	0	1,259
2026	3	224	0	—

https://510kreport.com/device/K913995 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913995: Vitalert 3000 Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913995

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026