510(k) · Cleared
ClearedSirscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligence Artificielle Applications · KZK Reader, Zone, Automated
Cleared on Nov 23, 1999 after a 210-day review. The FDA summary names no predicate by number.
- Decided
- Nov 23, 1999
- Review
- 210 days
- Class
- Class I
- Product code
- KZK
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 KZK? 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All KZK devicesKZK Reader, Zone, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZK
FDA has decided no KZK device since 2007.
Median 510(k) review, days · KZK
Too few KZK 510(k)s in any year since 2007 to give a median.
Recalls per year · KZK
No recall names KZK since 2007.
Adverse event reports per year · KZK
No MAUDE report names KZK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic…
Read the full statement (183 words)
The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the resuilts of susceptibility tests in other media can be keyed in manually.
The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated resuits reports, regularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results.
In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates; compares patient histories; classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics.
SIRSCAN can be connected to any laboratory management system, as well as to some micro-dilution systems (e.g., Vitek™, Microscan™).
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/K991473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991473: Sirscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991473
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026