510(k) · Cleared
ClearedSherlock Microbial Identification System for Biodef
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midi, Inc. · NWZ Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
Cleared on Jan 17, 2006 after a 130-day review. The FDA summary names no predicate by number.
- Decided
- Jan 17, 2006
- Review
- 130 days
- Class
- Class II
- Product code
- NWZ
- 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 NWZ? 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 NWZ devicesNWZ Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NWZ
FDA has decided no NWZ device since 2007.
Median 510(k) review, days · NWZ
Too few NWZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NWZ
No recall names NWZ since 2007.
Adverse event reports per year · NWZ
No MAUDE report names NWZ 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 MIDI Sherlock Microbial Identification System for BioDeffM is intended to aid in the identification of Bacillus anthracis through the analysis of membrane fatty acids derived from cultured bacterial samples, using gas chromatography and pattern recognition software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052485: Sherlock Microbial Identification System for Biodef.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052485
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026