510(k) · Cleared
ClearedIrma SL Blood Analysis System GL Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diametrics Medical, Inc. · GAA Needle, Aspiration And Injection, Disposable
Cleared on Nov 16, 2001 as substantially equivalent to K891480 (Yellow Springs Instrument Co., Inc., 1989) after a 177-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Nov 16, 2001
- Review
- 177 days
- Class
- Class I
- Product code
- GAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891480 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891480 Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerYellow Springs Instrument Co., Inc. · 1989
- This deviceK011586 Irma SL Blood Analysis System GL CartridgeDiametrics Medical, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891480 | Ysi Model 2300 Stat Glucose and L-Lactate Analyzer | Yellow Springs Instrument Co., Inc. | 1989 | — |
| 0 (this device) | K011586 | Irma SL Blood Analysis System GL Cartridge | Diametrics Medical, Inc. | 2001 | — |
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 GAA? 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 GAA device
- #1 K223625 CapnoSpot™ Pneumothorax Decompression Indicatorscore 5.1 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K891480 | Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerSummary page 1…,2001 GL Cartridge IRMA?® SL Blood Analysis System GL Cartridge Glucose Test System Glucose Class I 21 CFR 862.1345 Chemistry (75) CGA YSI Model 2300 Stat Plus. K891480 75 CGA The IRMA® SL Blood Analysis System GL Cartridge is substantially equivalent in method, intended use and clinical perform… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K891480.
How does its category compare?
All GAA devicesGAA Needle, Aspiration And Injection, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAA
Too few GAA 510(k)s in any year since 2007 to give a median.
Recalls per year · GAA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAA
348in 2025
MAUDE reports naming product code GAA, 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 | — | 0 | 12 |
| 2008 | 0 | — | 1 | 32 |
| 2009 | 0 | — | 2 | 20 |
| 2010 | 0 | — | 2 | 18 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 122 |
| 2019 | 0 | — | 10 | 153 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 0 | — | 5 | 108 |
| 2022 | 0 | — | 2 | 74 |
| 2023 | 1 | — | 0 | 118 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 0 | — | 0 | 348 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The glucose sensor is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of glucose, in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.
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/K011586 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011586: Irma SL Blood Analysis System GL Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011586
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026