510(k) · Cleared
ClearedPolymedco OC Auto Micro 80 Fob Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymedco, Inc. · OOX Automated Occult Blood Analyzer
Cleared on Oct 21, 2004 after a 147-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Oct 21, 2004
- Review
- 147 days
- Class
- Class II
- Product code
- OOX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK041408 Polymedco OC Auto Micro 80 Fob TestPolymedco, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK132167 I-Chroma Ifob with I-Chroma ReaderBoditech Med, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK200754 Hemosure Accu-Reader A100W.H.P.M., Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK163225 AFIAS iFOB with AFIAS-50Immunostics Inc., · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041408 | Polymedco OC Auto Micro 80 Fob Test | Polymedco, Inc. | 2004 | — |
| +1 | K132167 | I-Chroma Ifob with I-Chroma Reader | Boditech Med, Inc. | 2014 | — |
| +1 | K200754 | Hemosure Accu-Reader A100 | W.H.P.M., Inc. | 2022 | — |
| +2 | K163225 | AFIAS iFOB with AFIAS-50 | Immunostics Inc., | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OOX? 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 OOX device
- #1 K200754 Hemosure Accu-Reader A100score 3.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132167 (Boditech Med, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OOX devicesOOX Automated Occult Blood Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OOX
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OOX
Too few OOX 510(k)s in any year since 2007 to give a median.
Recalls per year · OOX
No recall names OOX since 2007.
Adverse event reports per year · OOX
No MAUDE report names OOX 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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (Gl) bieeding, found in a number of gastrointestinal (Gl) disorders, e.g., colitis, polyps, and colorectal cancer.
The OC Auto Micro FOB Test is recommended for use in
1. Routine physical examinations
2. Monitoring for bleeding in patients
3. Screening for colorectal cancer or gastrointestinal bleeding
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K041408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041408: Polymedco OC Auto Micro 80 Fob Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041408
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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