510(k) · Cleared
Clearedcobas u 701 microscopy analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LKM Counter, Urine Particle
Cleared on Nov 6, 2020 as substantially equivalent to K022774 (Intl. Remote Imaging Systems, 2002) after a 224-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Nov 6, 2020
- Review
- 224 days
- Class
- Class II
- Product code
- LKM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022774 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK022774 IQ 200 SystemIntl. Remote Imaging Systems · 2002 · Recalled
- This deviceK200811 cobas u 701 microscopy analyzerRoche Diagnostics · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022774 | IQ 200 System | Intl. Remote Imaging Systems | 2002 | 14 |
| 0 (this device) | K200811 | cobas u 701 microscopy analyzer | Roche Diagnostics | 2020 | — |
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 LKM? 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 LKM device
- #1 K252580 iQ200 Seriesscore 9.5 · 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? (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 |
|---|---|---|---|
| * | K022774 | IQ 200 SystemSummary page 5…assification Name cuvette Product Codes, See Table 1 Regulation Numbers Predicate Devices IRIS IQ 200 (k022774) For the cobas u 701 microscopy analyzer the establishment registration num… | 2002 |
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 a recall.
- 2 other devices also cite its predicate K022774.
How does its category compare?
All LKM devicesLKM Counter, Urine Particle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LKM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKM
Too few LKM 510(k)s in any year since 2007 to give a median.
Recalls per year · LKM
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKM
1in 2021
MAUDE reports naming product code LKM, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 4 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The cobas u 701 microscopy analyzer is a fully automated urine microscopy system intended for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, pathological casts, mucus and sperm in urine.
This system is intended to be used by trained operators in clinical laboratories. All instrument analyte image decisions may be reviewed and reclassified by a trained operator.
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/K200811 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200811: cobas u 701 microscopy analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200811
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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