510(k) · Cleared
ClearedAmira Medical Atlast Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amira Medical, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Dec 10, 1998 as substantially equivalent to K922888 (Lifescan, Inc., 1992) and 1 other predicate after a 181-day review. Its family tree reaches back 1 generation to 1992. 3 of the 37 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it.
- Decided
- Dec 10, 1998
- Review
- 181 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922888 (1992). 2 ancestors in all. 34 later devices descend from it, 2 citing it directly. 3 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK922888 One Touch Iib Blood Glucose MeterLifescan, Inc. · 1992
- This deviceK982076 Amira Medical Atlast Blood Glucose Monitoring SystemAmira Medical, Inc. · 1998
- Descendant · cites it directly · 33 of its ownK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 23 of its ownK012014 Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001
- Descendant · 2 generations on · 22 of its ownK020866 Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002
- Descendant · 2 generations on · 18 of its ownK031260 Freestyle Blood Glucose Monitoring System, Freestyle Tracker…Abbott Diabetes Care, Inc. · 2003
- Descendant · 2 generations on · 12 of its ownK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 34 · See all- K992684Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · cites it directly33descendants
- K012014Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001 · 2 generations on23descendants
- K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002 · 2 generations on22descendants
- K031260Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Abbott Diabetes Care, Inc. · 2003 · 2 generations on18descendants
- K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922888 | One Touch Iib Blood Glucose Meter | Lifescan, Inc. | 1992 | — |
| 0 (this device) | K982076 | Amira Medical Atlast Blood Glucose Monitoring System | Amira Medical, Inc. | 1998 | — |
| +1 | K992684 | Freestyle Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2000 | 2 |
| +2 | K012014 | Modification to Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2001 | — |
| +2 | K020866 | Freestyle Tracker Diabetes Management System | Abbott Diabetes Care, Inc. | 2002 | — |
| +2 | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes… | Abbott Diabetes Care, Inc. | 2003 | — |
| +2 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 2 |
| 2011 | 1 | 0 |
| 2012 | 4 | 1 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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.
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.
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 |
|---|---|---|---|
| * | K922888 | One Touch Iib Blood Glucose MeterSummary page 1…62.1345) Single analyte control (21 C.F.R. § 862.1660) Blood lancet (21 C.F.R. § 878.4800) Predicate Devices 1. LifeScan One Touch Basic Blood Glucose Monitoring System (K922888) 2. Boehringer Mannheim Accu-Chek Easy Blood Glucose Monitoring System (K923048) Amira Medical Confidential Revised: 11/24/98… | 1992 |
| * | K923048 | Accu-Chek Easy Blood Glucose SystemSummary page 1…878.4800) Predicate Devices 1. LifeScan One Touch Basic Blood Glucose Monitoring System (K922888) 2. Boehringer Mannheim Accu-Chek Easy Blood Glucose Monitoring System (K923048) Amira Medical Confidential Revised: 11/24/98 L44¥9/,1998 165:268 6599387262 MERCURY PAGE B5 Intended Use/Indi… | 1992 |
What descends from it? (34)
See all 342 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · 2 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 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K992684 (Abbott Diabetes Care, Inc., 2000) has gone furthest, with 33 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 Amira Medical ATLAST Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates (newborn children).
The ATLAST Blood Glucose Monitoring System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the thigh.
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/K982076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982076: Amira Medical Atlast 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/K982076
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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