510(k) · Cleared
Recalled · 2007IN Touch Diabetes Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifescan, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Apr 29, 1999 after a 129-day review. The FDA summary names its predicate without a number. 55 later devices descend from it. It has been recalled once.
- Decided
- Apr 29, 1999
- Review
- 129 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 1
- Predicates
- 0
55 later devices descend from it, 6 citing it directly.
- This deviceK984527 IN Touch Diabetes Management SoftwareLifescan, Inc. · 1999
- Descendant · cites it directly · 47 of its ownK040086 Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004
- Descendant · 2 generations on · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- Descendant · 2 generations on · 40 of its ownK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- Descendant · 2 generations on · 39 of its ownK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · 2 generations on · 30 of its ownK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K040086Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004 · cites it directly47descendants
- K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · 2 generations on45descendants
- K050567Health Buddy ApplianceHealth Hero Network, Inc. · 2005 · 2 generations on40descendants
- K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · 2 generations on39descendants
- K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984527 | IN Touch Diabetes Management Software | Lifescan, Inc. | 1999 | — |
| +1 | K040086 | Health Buddy with Buddylink | Health Hero Network, Inc. | 2004 | — |
| +2 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| +2 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| +2 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +2 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 9 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | — | LifeScan ONE TOUCH® Profile® Diabetes Tracking System Named without a submission number | |
| * | — | MediSense® Precision Link™ Blood Glucose Data Management System Named without a submission number |
What descends from it? (55)
See all 556 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040086 | Health Buddy with Buddylink | 2004 | 47 |
| K060504 | Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001 | 2006 | 5 |
| K080538 | Ideal Life Pod (Model Ilp 0001) | 2008 | 4 |
| K130657 | Linkdr 2.0 Diabetes Management Software | 2013 | 0 |
| K091229 | Glucomanager Data Management Software | 2009 | 0 |
| K081726 | Tysonbio Link Health Management System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2007 | Not classified | Z-1317-2008 | Software design | Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040086 (Health Hero Network, Inc., 2004) has gone furthest, with 47 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The IN TOUCH Diabetes Management Software System is intended for use in home and clinical settings to aid people with diabetes and health care professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan Brand blood glucose monitoring systems with data management capabilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984527 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984527: IN Touch Diabetes Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984527
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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