510(k) · Cleared

Cleared

Atlas Monitor

K984033510(k) TraditionalCleared Jul 8, 1999238-day reviewClass II21 CFR 870.2300

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

Welch Allyn, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cleared on Jul 8, 1999 as substantially equivalent to K951193 (Tycos Instruments, Inc., 1996) and 2 other predicates after a 238-day review. Its family tree reaches back 1 generation to 1991. 2 of the 271 devices in its family, counting itself, have a Class I recall. 267 later devices descend from it.

Decided: Jul 8, 1999
Review: 238 days
Class: Class II
Product code: DRT
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K911598 (1991). 3 ancestors in all. 267 later devices descend from it, 3 citing it directly. 2 of the 271 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK911598 Datascope Passport MonitorDatascope Corp. · 1991
This deviceK984033 Atlas MonitorWelch Allyn, Inc. · 1999
Descendant · cites it directly · 264 of its ownK022084 Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002
Descendant · 2 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
Descendant · 3 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
Descendant · 4 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
Descendant · 5 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009

Showing 5 of 267 descendants. See all descendants

Descendants cleared per year

2002high 24 (2022) · low 0 (2003)2026

Class I recalls in this family

K970209 Capnocheck Plusdirect predicate · 1997
K123690 CAPNOSTREAM20P with Hifi C02 Monitoring8 generations on · 2014

Most influential descendants

Showing 5 of 267 · See all

K022084Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002 · cites it directly264descendants
K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 2 generations on250descendants
K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 3 generations on197descendants
K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 4 generations on170descendants
K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 5 generations on155descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K911598	Datascope Passport Monitor	Datascope Corp.	1991	—
0 (this device)	K984033	Atlas Monitor	Welch Allyn, Inc.	1999	—
+1	K022084	Atlas Monitor, Models 200,210,220	Welch Allyn, Inc.	2002	—
+2	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…	Oridion Capnography, Inc.	2006	3
+3	K072295	Capnostream 20 with A2 Adaptive Averaging Software	Oridion Capnography, Inc.	2007	—
+4	K082268	CAPNOSTREAM20 with Integrated Pulmonary Index	Oridion Capnography, Inc.	2009	9
+5	K091241	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter	Masimo Corporation	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2006	2	0
2007	1	0
2008	1	0
2009	7	0
2010	8	0
2011	6	0
2012	15	0
2013	14	0
2014	18	1
2015	13	0
2016	12	0
2017	15	0
2018	15	0
2019	16	0
2020	16	0
2021	11	0
2022	24	0
2023	16	0
2024	20	0
2025	19	0
2026	16	0

FIG. 1 — Lineage of K984033, 1991–2026Source: 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.

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 DRT device

#1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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? (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
*	K951193	Clinical Vital Signs Monitor, Model #52STP-E1 Summary page 1 …al Name - Vital Signs Monitor Proprietary Name - Atlas Vital Signs Monitor Predicate Device: Welch Allyn Inc., Clinical Vital Signs Monitor model 52STP-E1 (ref. 510(k) #K951193), BCI International Inc., Capnocheck Plus model 9004 (ref. 510(k) #K970209, and the Datascope Corp., Passport Monitor Model XG (r…	Tycos Instruments, Inc.	1996	—
*	K970209	Capnocheck Plus Summary page 1 …Predicate Device: Welch Allyn Inc., Clinical Vital Signs Monitor model 52STP-E1 (ref. 510(k) #K951193), BCI International Inc., Capnocheck Plus model 9004 (ref. 510(k) #K970209, and the Datascope Corp., Passport Monitor Model XG (ref. 510(k) #K911598). Device Description, Intended Use & Effectiveness: T…	Bci Intl., Inc.	1997	Class I
*	K911598	Datascope Passport Monitor Summary page 1 …STP-E1 (ref. 510(k) #K951193), BCI International Inc., Capnocheck Plus model 9004 (ref. 510(k) #K970209, and the Datascope Corp., Passport Monitor Model XG (ref. 510(k) #K911598). Device Description, Intended Use & Effectiveness: The Atlas Monitor (including model numbers 200, 210, and 220) is a multi- p…	Datascope Corp.	1991	—

Also cleared against K951193: 5 other devices →

What descends from it? (267)

See all 267

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

Number	Device	Applicant	Decided	Descendants
K022084	Atlas Monitor, Models 200,210,220	Welch Allyn, Inc.	2002	264
K152701	Matrix Mini ECG Monitor	Global Instrumentation, LLC	2016	3
K160667	Anybattery C2 Rechargeable Battery	Anybattery, Inc.	2017	0

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.

K970209Capnocheck PlusBci Intl., Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K022084 (Welch Allyn, Inc., 2002) has gone furthest, with 264 descendants of its own.
5 other devices also cite its predicate K951193.

How does its category compare?

All DRT devices

DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRT

1in 2025

2007high 6 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRT

228in 2024

2007high 228 (2024) · low 44 (2010)2026

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

Recalls per year · DRT

1in 2024

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRT

40in 2025

2007high 447 (2019) · low 16 (2013)2025

MAUDE reports naming product code DRT, 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	1	—	0	113
2008	1	—	0	99
2009	6	70	0	118
2010	3	44	0	63
2011	3	149	1	36
2012	1	—	0	47
2013	1	—	0	16
2014	0	—	0	26
2015	1	—	0	48
2016	1	—	0	55
2017	1	—	0	159
2018	1	—	0	224
2019	1	—	0	447
2020	0	—	0	50
2021	2	—	1	85
2022	1	—	0	35
2023	1	—	0	47
2024	3	228	1	29
2025	1	—	0	40
2026	5	120	0	—

What is it indicated for?

The indications for use for the Atlas Monitor, model numbers 200, 210, and 220, include the monitoring of the following human physiological vital signs:

Blood Oxygenation (SpO,) measurement

ECG waveform derived from 3 or 5 Lead measurement

Respiration rate/waveform derived from ECG or CO,

Temperature measurement via YSI 400 series probes

Non Invasive Blood Pressure (NIBP) measurement

CO,, End-tidal sidestream/waveform

Heart Rate derived from selected source (ECG, SpO,)

The target populations are adult and pediatric populations. The monitor is intended for use within the healthcare facility setting.

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/K984033 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984033: Atlas Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984033

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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