510(k) · Cleared
ClearedGenesis Health Record System, (GHRS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Health Technologies · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Mar 7, 2013 as substantially equivalent to K100937 (I-Sens, Inc., 2010) after a 153-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 7, 2013
- Review
- 153 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K952279 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- 3 generations backK994433 Connect Data Management SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 2 generations backK062434 Zero-Click Data Management System, Model 8000-01528Agamatrix · 2006
- 1 generation backK100937 PC Care Blood Glucose Data Management SoftwareI-Sens, Inc. · 2010
- This deviceK123136 Genesis Health Record System, (GHRS)Genesis Health Technologies · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| −3 | K994433 | Connect Data Management System | Abbott Diabetes Care, Inc. | 2000 | 1 |
| −2 | K062434 | Zero-Click Data Management System, Model 8000-01528 | Agamatrix | 2006 | — |
| −1 | K100937 | PC Care Blood Glucose Data Management Software | I-Sens, Inc. | 2010 | — |
| 0 (this device) | K123136 | Genesis Health Record System, (GHRS) | Genesis Health Technologies | 2013 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K100937 | PC Care Blood Glucose Data Management SoftwareSummary page 1…Processing Module for Clinical Use Predicate Device ISENS PC care blood Glucose data Management Software 807.92(a)(3) K1 00937 Device Description 1. The Genesis Health Record System (GHRS) is an internet 807.92(a)(4)… | 2010 |
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 18 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2013, 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 Genesis Health Record System is an accessory to the Genesis Health Technologies Blood Glucose Meter, Model TD-4123 to assist in the review and evaluation of blood glucose test results and related information to aid in diabetes management. It is indicated for use by adult diabetic patients for use in the home and by healthcare professionals in the professional setting. The System is not intended to provide automated treatment guidance or decisions. The System is not indicated for the diagnosis or screening of diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123136: Genesis Health Record System, (GHRS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123136
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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