510(k) · Cleared
ClearedSurestep Blood Glucose Monitoring System
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 May 21, 1999 as substantially equivalent to K942455 (Lifescan, Inc., 1995) and 1 other predicate after a 175-day review. Its family tree reaches back 1 generation to 1995. 15 later devices descend from it.
- Decided
- May 21, 1999
- Review
- 175 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942455 (1995). 2 ancestors in all. 15 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
- This deviceK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK051285 Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2005
- Descendant · 2 generations on · 2 of its ownK091157 Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd. · 2009
- Descendant · 3 generations on · 1 of its ownK113192 Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK082201 G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK052469 GlucopackHealthpia America Corp. · 2006
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K051285Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2005 · cites it directly6descendants
- K091157Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd. · 2009 · 2 generations on2descendants
- K113192Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012 · 3 generations on1descendant
- K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009 · cites it directly1descendant
- K052469GlucopackHealthpia America Corp. · 2006 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942455 | Lifescan Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1995 | — |
| 0 (this device) | K984261 | Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1999 | — |
| +1 | K051285 | Glucolab Blood Glucose Monitoring System | Infopia Co, Ltd. | 2005 | — |
| +2 | K091157 | Gluco Lab Auto Coding, Model Igm-0022 | Infopia Co, Ltd. | 2009 | — |
| +3 | K113192 | Healthpro Blood Glucose Monitoring System | Infopia Co, Ltd. | 2012 | — |
| +1 | K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A | U. S. Diagnostics, Inc. | 2009 | — |
| +1 | K052469 | Glucopack | Healthpia America Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K942455 | Lifescan Surestep Blood Glucose Monitoring SystemSummary page 1…es. Substantial Equivalence The LifeScan SURESTEP Blood Glucose Monitoring System is substantially equivalent to the original SURESTEP Blood Glucose Monitoring System, K942455, and the SURESTEPPRO Blood Glucose Monitoring System, k970556. 015 é DEPARTMENT OF HEALTH & HUMAN SERVICES Publi… | 1995 |
| * | K970556 | Surestep Pro Blood Glucose Monitoring SystemSummary page 1…ose Monitoring System is substantially equivalent to the original SURESTEP Blood Glucose Monitoring System, K942455, and the SURESTEPPRO Blood Glucose Monitoring System, k970556. 015 é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 0L 9200 Corpora… | 1997 |
What descends from it? (15)
See all 158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051285 | Glucolab Blood Glucose Monitoring System | 2005 | 6 |
| K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A | 2009 | 1 |
| K052469 | Glucopack | 2006 | 1 |
| K061431 | Easygluco, Model Igm-0002 G2 | 2007 | 0 |
| K051651 | G4, Model Igm-0004 | 2006 | 0 |
| K043512 | Easygluco Igm-0002 G2 | 2005 | 0 |
| K043543 | Blood Glucose Monitoring System | 2005 | 0 |
| K031501 | Easygluco, Model IGM0002 | 2003 | 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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K051285 (Infopia Co, Ltd., 2005) has gone furthest, with 6 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 LifeScan SureStep Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates.
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/K984261 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984261: Surestep Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984261
Report an extraction error
Are you the manufacturer?
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