510(k) · Cleared
ClearedAccu-Chek Advantage Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LFR Glucose Dehydrogenase, Glucose
Cleared on Feb 15, 1996 after a 118-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 63 devices in its family, counting itself, have a Class I recall. 62 later devices descend from it.
- Decided
- Feb 15, 1996
- Review
- 118 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 0
62 later devices descend from it, 3 citing it directly. 3 of the 63 devices in this family, counting this one, have a Class I recall.
- This deviceK954833 Accu-Chek Advantage Test StripsBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 59 of its ownK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- Descendant · 2 generations on · 40 of its ownK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- Descendant · 3 generations on · 19 of its ownK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- Descendant · 3 generations on · 16 of its ownK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- Descendant · 2 generations on · 14 of its ownK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 62 · See all- K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997 · cites it directly59descendants
- K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…Medisense, Inc. · 1999 · 2 generations on40descendants
- K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005 · 3 generations on19descendants
- K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · 3 generations on16descendants
- K982303Precision PCX Point of Care Management System , QC Manager Data Manager System…Medisense, Inc. · 1998 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954833 | Accu-Chek Advantage Test Strips | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| +2 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| +3 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| +3 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| +2 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 3 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (62)
See all 623 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | 1997 | 59 |
| K982089 | Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test Strips | 1998 | 0 |
| K973662 | Accu-Chek (R)Complete System/Meter & Accu-Chek Advantage Test Strips/Accu-Chek Advantage… | 1997 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 110 Class I recalls
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · 6 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2010 · 7 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K971812 (Medisense, Inc., 1997) has gone furthest, with 59 descendants of its own.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K954833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954833: Accu-Chek Advantage Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954833
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026