510(k) · Cleared
ClearedGluco Lab Auto Coding, Model Igm-0022
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infopia Co, Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 17, 2009 as substantially equivalent to K051285 (Infopia Co, Ltd., 2005) after a 210-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 17, 2009
- Review
- 210 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942455 (1995). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
- 2 generations backK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
- 1 generation backK051285 Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2005
- This deviceK091157 Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK113192 Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK132862 Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942455 | Lifescan Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1995 | — |
| −2 | K984261 | Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1999 | — |
| −1 | K051285 | Glucolab Blood Glucose Monitoring System | Infopia Co, Ltd. | 2005 | — |
| 0 (this device) | K091157 | Gluco Lab Auto Coding, Model Igm-0022 | Infopia Co, Ltd. | 2009 | — |
| +1 | K113192 | Healthpro Blood Glucose Monitoring System | Infopia Co, Ltd. | 2012 | — |
| +2 | K132862 | Healthpro Professional Blood Glucose Monitoring System | Infopia Co, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K051285 | Glucolab Blood Glucose Monitoring SystemSummary page 1…2.1345, NBW/CGA) Quality control material (assayed and unassayed) (21 CFR Part 862.1660, JJX) 6. The legally marketed (Unmodified) Device / Predicate GLUCOLAB T M (K051285) Blood Glucose Monitoring System, Infopia co., Ltd. 7. Device Description GLUCOLAB Auto-codingT Blood Glucose Monitoring System… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113192 | Healthpro Blood Glucose Monitoring System | 2012 | 1 |
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 14 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K113192 (Infopia Co, Ltd., 2012) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K051285.
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. 2009, 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 GLUCOLAB Auto-coding TM Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings, including physician's office laboratories and point of care sites. The GLUCOLAB Auto-coding TM System provides plasma equivalent results. The GLUCOLAB Auto-coding TM System is not intended to be used with neonatal blood…
Read the full statement (164 words)
The GLUCOLAB Auto-coding TM Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings, including physician's office laboratories and point of care sites. The GLUCOLAB Auto-coding TM System provides plasma equivalent results. The GLUCOLAB Auto-coding TM System is not intended to be used with neonatal blood samples. The GLUCOLAB Auto-coding TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
GLUCOLAB Auto-coding TM control is used with GLUCOLAB Auto-coding TM Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you do control solution tests routinely to make sure you are getting accurate results.
Control Solutions are sold separately.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091157: Gluco Lab Auto Coding, Model Igm-0022.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091157
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