510(k) · Cleared
ClearedMini-Medic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Athena Gtx · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 2, 2012 as substantially equivalent to K101674 (Athena Gtx, 2010) and 4 other predicates after a 99-day review. Its family tree reaches back 9 generations to 1997. 13 later devices descend from it.
- Decided
- Feb 2, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K962603 (1997). 37 ancestors in all, the oldest K904039 (1990). 13 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 2 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 1 generation backK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
- This deviceK113165 Mini-MedicAthena Gtx · 2012
- Descendant · cites it directly · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK222658 Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK250415 G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 4 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 3 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 2 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 1 generation backK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
- This deviceK113165 Mini-MedicAthena Gtx · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · cites it directly12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 2 generations on5descendants
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · 3 generations on2descendants
- K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023 · 2 generations on2descendants
- K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −4 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −3 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −2 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| −1 | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | Athena Gtx | 2010 | — |
| 0 (this device) | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
| +1 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +2 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +3 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +2 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | — |
| +2 | K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
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
What was it cleared against? (5)
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 | Decided |
|---|---|---|---|
| * | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0Summary page 1…ation: Class 11 Basis for Submission: New device design Legally Marketed (Predicate) Devices: Athena GTX Wireless Vital Signs Monitor (WVSM) K101674 Envitec-Wismar GmbH OxiPen Pulse Oximeter K070193 Exergen Temporal Scann… | 2010 |
| * | K070193 | Envitec Oxipen Pulse Oximeter and AccessoriesSummary page 1…Legally Marketed (Predicate) Devices: Athena GTX Wireless Vital Signs Monitor (WVSM) K101674 Envitec-Wismar GmbH OxiPen Pulse Oximeter K070193 Exergen Temporal Scanner Thermometer K01 1291 Nihon Kohden BSM-2300 Ser… | 2007 |
| * | K011291 | Temporalscanner Thermometer, SensortouchSummary page 1…ns Monitor (WVSM) K101674 Envitec-Wismar GmbH OxiPen Pulse Oximeter K070193 Exergen Temporal Scanner Thermometer K01 1291 Nihon Kohden BSM-2300 Series Bedside Monitors K01 1918 Nonin 8000R Refl… | 2001 |
| * | K011918 | Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A SeriesSummary page 1…se Oximeter K070193 Exergen Temporal Scanner Thermometer K01 1291 Nihon Kohden BSM-2300 Series Bedside Monitors K01 1918 Nonin 8000R Reflectance Sensor (specified accessory in Nonin 2500A monit… | 2001 |
| * | K050056 | Model 2500A Palmsat Pulse OximeterSummary page 1…300 Series Bedside Monitors K01 1918 Nonin 8000R Reflectance Sensor (specified accessory in Nonin 2500A monitor) K050056 r 5- I… | 2005 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190792 | BB-613WP | 2019 | 12 |
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 15 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 9 of the 37 ancestors have a recall of any class.
- Of its descendants, K190792 (Biobeat Technologies, Ltd., 2019) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K101674.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 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 mini-MedicTM system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over. The mini-Medic TM system is indicated as a single or multi-parameter vital signs monitor for Sp02 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from EGG electrodes, and forehead skin surface temperature from an infrared temperature sensor. Pulse…
Read the full statement (258 words)
The mini-MedicTM system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over.
The mini-Medic TM system is indicated as a single or multi-parameter vital signs monitor for Sp02 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from EGG electrodes, and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from the integrated SpO2 forehead sensor and EGG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions.
Patient data may be entered on the Handheld Display Unit. The mini-MedicTh system provides vital parameter alarms and a patient composite/summary alarm.
Patient information and system commands are transmitted using wireless radio communications between the Forehead Sensor Unit and the Handheld Display Unit. Stored patient data may be output, printed, downloaded and saved via a dedicated mini-MedicTM PC Software application.
Typical locations for the use of the mini-Med ic TM system are: pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport. The monitor is intended to be used by trained healthcare providers in military and civilian roles including doctors, nurses, combat medics, combat lifesavers, EMT's, and paramedics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113165: Mini-Medic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113165
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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