510(k) · Cleared

Recalled · Class II · 2012

Model 3200 Vascular Mini-Lab

K944495510(k) TraditionalCleared Jun 2, 1995262-day reviewClass II21 CFR 870.1025Recalls 1

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

Parks Medical Electronics, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jun 2, 1995 after a 262-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided: Jun 2, 1995
Review: 262 days
Class: Class II
Product code: MHX
Recalls: 1
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK944495 Model 3200 Vascular Mini-LabParks Medical Electronics, Inc. · 1995
Descendant · cites it directly · 1 of its ownK093192 Flochec Photo Plethysmographic DeviceAdvanced Vascular Dynamics · 2010
Descendant · 2 generations on · 0 of its ownK143094 QuantaFloSemler Scientific, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K093192Flochec Photo Plethysmographic DeviceAdvanced Vascular Dynamics · 2010 · cites it directly1descendant
K143094QuantaFloSemler Scientific, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944495	Model 3200 Vascular Mini-Lab	Parks Medical Electronics, Inc.	1995	—
+1	K093192	Flochec Photo Plethysmographic Device	Advanced Vascular Dynamics	2010	—
+2	K143094	QuantaFlo	Semler Scientific, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2015	1	0

FIG. 1 — Lineage of K944495, 1995–2015Source: 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.

Planning a device in MHX? 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 MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K093192	Flochec Photo Plethysmographic Device	Advanced Vascular Dynamics	2010	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 8, 2012	Class II	Z-0443-2013	Employee error	Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K093192 (Advanced Vascular Dynamics, 2010) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

https://510kreport.com/device/K944495 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944495: Model 3200 Vascular Mini-Lab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944495

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Record history

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