510(k) · Cleared
Recalled · 2007Axsym Gentamicin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Mfg., Inc. · LCD Enzyme Immunoassay, Gentamicin
Cleared on Jun 21, 1994 after a 225-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 21, 1994
- Review
- 225 days
- Class
- Class II
- Product code
- LCD
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK935376 Axsym GentamicinAbbott Mfg., Inc. · 1994
- Descendant · cites it directly · 1 of its ownK102699 Architect Igentamicin Reagents; Architect Igentamicin CalibratorsAbbott Laboratories · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK243500 ARCHITECT iGentamicinAbbott Laboratories · 2025
- Descendant · cites it directly · 0 of its ownK012311 Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600…Diagnostic Products Corp. · 2001
Most influential descendants
Showing 3 of 3 · See all- K102699Architect Igentamicin Reagents; Architect Igentamicin CalibratorsAbbott Laboratories · 2011 · cites it directly1descendant
- K243500ARCHITECT iGentamicinAbbott Laboratories · 2025 · 2 generations on0descendants
- K012311Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)Diagnostic Products Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935376 | Axsym Gentamicin | Abbott Mfg., Inc. | 1994 | — |
| +1 | K102699 | Architect Igentamicin Reagents; Architect Igentamicin Calibrators | Abbott Laboratories | 2011 | 1 |
| +2 | K243500 | ARCHITECT iGentamicin | Abbott Laboratories | 2025 | — |
| +1 | K012311 | Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests) | Diagnostic Products Corp. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2011 | 1 | 0 |
| 2025 | 1 | 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.
Planning a device in LCD? 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 LCD device
- #1 K243500 ARCHITECT iGentamicinscore 9.9 · 2 generations · no Class I recall
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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2007 | Not classified | Z-0930-2008 | Other | Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may produce the following results: - Printed Error Code "SPAN LESS THAN MIN SPAN" - Controls… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K102699 (Abbott Laboratories, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LCD devicesLCD Enzyme Immunoassay, Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCD
Too few LCD 510(k)s in any year since 2007 to give a median.
Recalls per year · LCD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCD
2in 2024
MAUDE reports naming product code LCD, 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 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 4 | 3 |
| 2010 | 0 | — | 1 | 4 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 19 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935376: Axsym Gentamicin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935376
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026