510(k) · Cleared

Cleared

PMP4 BP Pro Blood Pressure Monitor

K060703510(k) SpecialCleared Apr 4, 200619-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

Card Guard Scientific Survival, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Apr 4, 2006 as substantially equivalent to K053395 (Card Guard Scientific Survival, Ltd., 2005) and 3 other predicates after a 19-day review. Its family tree reaches back 4 generations to 1997.

Decided: Apr 4, 2006
Review: 19 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K963725 (1997). 16 ancestors in all, the oldest K942704 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
3 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
2 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
1 generation backK050853 PMP4 SpiroproCard Guard Scientific Survival, Ltd. · 2005
This deviceK060703 PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K963725	Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)	Card Guard, Ltd.	1997	—
−3	K012223	CG-2211 Selfcheck Ecg Transmitter	Card Guard Scientific Survival, Ltd.	2001	—
−2	K042254	PMP4 Selfcheck Ecg	Card Guard Scientific Survival, Ltd.	2005	—
−1	K050853	PMP4 Spiropro	Card Guard Scientific Survival, Ltd.	2005	—
0 (this device)	K060703	PMP4 BP Pro Blood Pressure Monitor	Card Guard Scientific Survival, Ltd.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0
1997	1	0
1999	2	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2005	2	0
2006	1	0

FIG. 1 — Lineage of K060703, 1997–2006Source: 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

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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
*	K053395	BP Pro Blood Pressure Monitor Summary page 2 …the reduced discomfort for the patient. 5. Substantial Equivalence Substantial equivalence (SE) is claimed to the following predicate devices: 1. Card Guard's BP Pro K053395 - for physical and functional identity and close similarity in IU. 2. Card Guard's CG-7000DX-BT K052556 - for the remote communic…	Card Guard Scientific Survival, Ltd.	2005	—
*	K052556	CG-7000DX-BT Ecg Recorder/Transmitter Summary page 2 …laimed to the following predicate devices: 1. Card Guard's BP Pro K053395 - for physical and functional identity and close similarity in IU. 2. Card Guard's CG-7000DX-BT K052556 - for the remote communication functionality. 3. Card Guard's PMP 4 Spiro Pro K050853 - for including the PMP 4 Medical Applicati…	Card Guard Scientific Survival, Ltd.	2006	—
*	K050853	PMP4 Spiropro Summary page 2 …al and functional identity and close similarity in IU. 2. Card Guard's CG-7000DX-BT K052556 - for the remote communication functionality. 3. Card Guard's PMP 4 Spiro Pro K050853 - for including the PMP 4 Medical Application. 4. Card Guard's PMP 4 Medical Web Center K050940 - for multiple-format medical dat…	Card Guard Scientific Survival, Ltd.	2005	—
*	K050940	PMP4 Medical Web Center Summary page 2 …r the remote communication functionality. 3. Card Guard's PMP 4 Spiro Pro K050853 - for including the PMP 4 Medical Application. 4. Card Guard's PMP 4 Medical Web Center K050940 - for multiple-format medical data feature. 6. PMP 4 Medical Application The PMP 4 Medical Application is designed for wireles…	Card Guard Scientific Survival, Ltd.	2005	—

What descends from it?

No later submission names this one as a predicate yet.

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 9 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
None of the 16 ancestors has a recall.

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 PMIr BP Pro Blood Pressure Monitor is intended to be used for monitoring Blood Pressure (BP) and Heart Rate (HR) from the upper arm. BP and HR can be recorded and transferred to a remote hand held device/PC for viewing and processing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060703 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060703: PMP4 BP Pro Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060703

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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