510(k) · Cleared

Cleared

VITALLINK3 Mobile Vital Signs System

K073094510(k) SpecialCleared Jan 4, 200864-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

Telemedic Systems, Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Jan 4, 2008 as substantially equivalent to K010732 (Telemedic Systems, Inc., 2001) after a 64-day review. Its family tree reaches back 1 generation to 2001.

Decided: Jan 4, 2008
Review: 64 days
Class: Class II
Product code: MWI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010732 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK010732 Vitallink 1200 Mobile Vital Signs Systems (VL 1200 System)Telemedic Systems, Inc. · 2001
This deviceK073094 VITALLINK3 Mobile Vital Signs SystemTelemedic Systems, Ltd. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010732	Vitallink 1200 Mobile Vital Signs Systems (VL 1200 System)	Telemedic Systems, Inc.	2001	—
0 (this device)	K073094	VITALLINK3 Mobile Vital Signs System	Telemedic Systems, Ltd.	2008	—

FIG. 1 — Lineage of K073094, 2001–2008Source: 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 MWI? 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 MWI device

#1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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? (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
*	K010732	Vitallink 1200 Mobile Vital Signs Systems (VL 1200 System) Summary page 3 …on A 112307 7. Statement of Substantial Equivalence TeleMedic Systems believes that the VitalLink3 is a modification of the VitalLink1 200 (K010732) as it has the same indications for use and does not include a change in the fundamental science incorporated in the p…	Telemedic Systems, Inc.	2001	—

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?

Its one ancestor has no recall.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MWI

4in 2025

2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007high 255 (2019) · low 42 (2007)2026

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

Recalls per year · MWI

9so far in 2026, the most since 2007

2007high 9 (2026) · low 0 (2016)2026

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

Adverse event reports per year · MWI

182in 2025

2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, 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	9	42	1	3
2008	9	49	1	3
2009	6	112	2	20
2010	17	58	2	17
2011	11	78	3	16
2012	13	104	5	31
2013	20	85	3	42
2014	16	148	6	30
2015	19	127	1	31
2016	12	165	0	51
2017	13	205	2	85
2018	11	217	0	158
2019	14	255	4	169
2020	8	138	0	110
2021	9	161	0	188
2022	5	231	2	168
2023	8	250	0	179
2024	10	202	5	120
2025	4	247	0	182
2026	6	239	9	—

What is it indicated for?

The VitalLink (VL3) Mobile Vital Signs System is intend for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs from patients in remote locations and transmit the data, real time, to a medical professional at a Medical Call Center / Medical Service Provider in order to help determine the patient's transportation needs.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073094 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073094: VITALLINK3 Mobile Vital Signs System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073094

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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