510(k) · Cleared
ClearedPC Care Blood Glucose Data Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Sens, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Dec 21, 2010 as substantially equivalent to K062434 (Agamatrix, 2006) after a 260-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Dec 21, 2010
- Review
- 260 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952279 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- 2 generations backK994433 Connect Data Management SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 1 generation backK062434 Zero-Click Data Management System, Model 8000-01528Agamatrix · 2006
- This deviceK100937 PC Care Blood Glucose Data Management SoftwareI-Sens, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK123136 Genesis Health Record System, (GHRS)Genesis Health Technologies · 2013
Most influential descendants
Showing 1 of 1 · See all- K123136Genesis Health Record System, (GHRS)Genesis Health Technologies · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| −2 | K994433 | Connect Data Management System | Abbott Diabetes Care, Inc. | 2000 | 1 |
| −1 | K062434 | Zero-Click Data Management System, Model 8000-01528 | Agamatrix | 2006 | — |
| 0 (this device) | K100937 | PC Care Blood Glucose Data Management Software | I-Sens, Inc. | 2010 | — |
| +1 | K123136 | Genesis Health Record System, (GHRS) | Genesis Health Technologies | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K062434 | Zero-Click Data Management System, Model 8000-01528Summary page 3…ata Management System 2) Device Company: AgaMatrix, Inc. 3) Predicate 510(k) Number(s) :1k062434 M. Comparison with The glucose measurement test principle: Predicate Device same as Zero-Clickm Da… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123136 | Genesis Health Record System, (GHRS) | 2013 | 0 |
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 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K123136 (Genesis Health Technologies, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062434.
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. 2010, 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 PC care TMBlood Glucose Data Management Software is PC-based software intended for use in the home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for an effective diabetes management program. The PC care Blood Glucose Data Management Software connects to an 1-SENS blood glucose meter, which comes with a PC care USB cable. The PC carem Blood Glucose Data Management Software allows the user to download Blood glucose readings automatically ftom the meter to the PC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100937: PC Care Blood Glucose Data Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100937
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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