510(k) · Cleared
ClearedHemosure Accu-Reader A100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.H.P.M., Inc. · OOX Automated Occult Blood Analyzer
Cleared on Jun 2, 2022 as substantially equivalent to K041408 (Polymedco, Inc., 2004) after an 801-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jun 2, 2022
- Review
- 801 days
- Class
- Class II
- Product code
- OOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041408 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041408 Polymedco OC Auto Micro 80 Fob TestPolymedco, Inc. · 2004
- This deviceK200754 Hemosure Accu-Reader A100W.H.P.M., Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041408 | Polymedco OC Auto Micro 80 Fob Test | Polymedco, Inc. | 2004 | — |
| 0 (this device) | K200754 | Hemosure Accu-Reader A100 | W.H.P.M., Inc. | 2022 | — |
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 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 K191147 OC-Auto SENSOR io iFOB Testscore -1.4 · 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.
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.
- 1 other device also cites its predicate K041408.
How does its category compare?
All OOX devicesOOX Automated Occult Blood Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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?
Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories.
Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.
For in vitro diagnostic use. For Prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200754: Hemosure Accu-Reader A100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200754
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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