510(k) · Cleared

Cleared

Zoll M Series Nibp Option

K032363510(k) TraditionalCleared Oct 31, 200392-day reviewClass II21 CFR 870.1130

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

Zoll Medical Corp · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Oct 31, 2003 as substantially equivalent to K012451 (Welch Allyn Protocol, Inc., 2001) after a 92-day review. Its family tree reaches back 5 generations to 1997. 114 later devices descend from it.

Decided: Oct 31, 2003
Review: 92 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K962603 (1997). 9 ancestors in all, the oldest K945071 (1995). 114 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
1 generation backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
This deviceK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
Descendant · cites it directly · 64 of its ownK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
Descendant · 2 generations on · 27 of its ownK090989 Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
Descendant · cites it directly · 25 of its ownK082599 Non-Invasive Continuous Blood Pressure Monitoring System Cnap…Cnsystem Medizintechnik AG · 2008
Descendant · 3 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
Descendant · 2 generations on · 21 of its ownK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled

Showing 5 of 114 descendants. See all descendants

Descendants cleared per year

2005high 10 (2015) · low 1 (2005)2026

Most influential descendants

Showing 5 of 114 · See all

K042007Zoll E Series DefibrillatorZoll Medical Corp · 2005 · cites it directly64descendants
K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009 · 2 generations on27descendants
K082599Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATCnsystem Medizintechnik AG · 2008 · cites it directly25descendants
K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 3 generations on24descendants
K060559Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · 2 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−4	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−3	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−2	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
−1	K012451	Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246	Welch Allyn Protocol, Inc.	2001	—
0 (this device)	K032363	Zoll M Series Nibp Option	Zoll Medical Corp	2003	—
+1	K042007	Zoll E Series Defibrillator	Zoll Medical Corp	2005	3
+2	K090989	Zoll R Series with Nibp and ETCO2 Options, Zoll R Series	Zoll Medical Corp	2009	—
+1	K082599	Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I…	Cnsystem Medizintechnik AG	2008	—
+3	K151644	Masimo Root Vital Signs Monitoring System and Accessories	Masimo Corporation	2016	—
+2	K060559	Zoll R Series Defibrillator	ZOLL Medical Corporation	2006	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	2	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	1	0
2008	5	0
2009	6	0
2010	3	0
2011	7	0
2012	7	0
2013	3	0
2014	8	0
2015	10	0
2016	3	0
2017	4	0
2018	8	0
2019	6	0
2020	8	0
2021	4	0
2022	5	0
2023	6	0
2024	8	0
2025	6	0
2026	3	0

FIG. 1 — Lineage of K032363, 1997–2026Source: 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.

Planning a device in DXN? 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 DXN device

#1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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? (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
*	K012451	Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246	Welch Allyn Protocol, Inc.	2001	—

Also cleared against K012451: 12 other devices →

What descends from it? (114)

See all 114

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

Number	Device	Applicant	Decided	Descendants
K042007	Zoll E Series Defibrillator	Zoll Medical Corp	2005	64
K082599	Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT	Cnsystem Medizintechnik AG	2008	25
K113623	Patient Monitor	Edan Instruments, Inc.	2012	15
K120173	Patient Monitor	Edan Instruments, Inc.	2012	10
K051907	Innocor	Innovision A/S	2006	4
K090801	Electronic House Call	Express MD Solutions, LLC	2009	3

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?

The line of descent spans 6 years and passes through 5 companies; a new generation was cleared every 11 months on median.
1 of the 9 ancestors has a recall of any class.
Of its descendants, K042007 (Zoll Medical Corp, 2005) has gone furthest, with 64 descendants of its own.
12 other devices also cite its predicate K012451.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

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

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, 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	27	118	0	21
2008	23	82	1	8
2009	46	73	3	17
2010	43	94	0	14
2011	34	72	1	10
2012	36	116	0	19
2013	34	150	1	72
2014	29	133	0	47
2015	30	97	0	62
2016	30	144	1	54
2017	33	184	0	90
2018	22	235	0	617
2019	33	156	1	96
2020	24	198	0	130
2021	23	190	0	162
2022	25	137	0	155
2023	35	182	0	162
2024	17	107	3	270
2025	28	142	0	239
2026	29	147	0	—

What is it indicated for?

The ZOLL M Series NIBP Option is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032363 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032363: Zoll M Series Nibp Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032363

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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