510(k) · Cleared
ClearedMedapps Remote Patient Monitoring, Model MA 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medapps, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 3, 2007 as substantially equivalent to K061328 (E-San Limited, 2006) and 1 other predicate after a 322-day review. Its family tree reaches back 8 generations to 1987. 20 later devices descend from it.
- Decided
- Jul 3, 2007
- Review
- 322 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K864318 (1987). 22 ancestors in all, the oldest K790130 (1979). 20 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 6 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 5 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 4 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 3 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 2 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 1 generation backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- This deviceK062377 Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
- Descendant · cites it directly · 4 of its ownK112559 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · cites it directly12descendants
- K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013 · 2 generations on4descendants
- K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011 · cites it directly4descendants
- K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010 · cites it directly4descendants
- K133252Healthinterlink BeaconHealthinterlink, LLC · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −7 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −6 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −5 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −4 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −3 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −2 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −1 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| 0 (this device) | K062377 | Medapps Remote Patient Monitoring, Model MA 100 | Medapps, Inc. | 2007 | — |
| +1 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +2 | K124000 | Medapps 2.0 - Remote Patient Monitoring System | Medapps Inc., Dba Alere Connect | 2013 | — |
| +1 | K112559 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2011 | — |
| +1 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +2 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K061328 | Think Positive Diabetes Management System (T+Diabetes System)Summary page 1…e: April 3, 2007 A. LEGALLY MARKETED PREDICATE DEVICE - as required by 807.92(a)(3) Legallv marketed predicate device are: K061328 Think Positive (t+) Diabetes Management System K050929 The Hermes System The submitted device is inten… | 2006 |
| * | K050929 | The Hermes SystemSummary page 1…ATE DEVICE - as required by 807.92(a)(3) Legallv marketed predicate device are: K061328 Think Positive (t+) Diabetes Management System K050929 The Hermes System The submitted device is intended to be an accessory device to the LifeScan OneTouch® Ultra… | 2005 |
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K083862 (Medapps, Inc., 2009) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K061328.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The MedApps Remote Patient Monitoring System model d-PAL acts as an accessory to FDA cleared devices, which collects and transmits stored patient data via wireless connections from medical devices to a cellular phone (Hub) and forwards to a central server for review of historical data about a patient over time to benefit the Healthcare Practitioner. The following medical devices and measuring systems are fully validated for this intended use at this…
Read the full statement (203 words)
The MedApps Remote Patient Monitoring System model d-PAL acts as an accessory to FDA cleared devices, which collects and transmits stored patient data via wireless connections from medical devices to a cellular phone (Hub) and forwards to a central server for review of historical data about a patient over time to benefit the Healthcare Practitioner.
The following medical devices and measuring systems are fully validated for this intended use at this time:
• LifeScan OneTouch ® Ultra® Blood Glucose Monitoring System
(k024194/k043197)
* Polytel PWR-08-03 Remote Module (k070559)
The MedApps Remote Patient Monitoring System is not intended to provide automated treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The MedApps Remote Patient Monitoring System is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted. This device is not for use in systems which substitute for medical care. This device is not intended for patients requiring direct medical supervision or emergency intervention,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062377: Medapps Remote Patient Monitoring, Model MA 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062377
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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