510(k) · Cleared
Recalled · Class III · 2019Hemosure One-Step Fecal Occult Blood Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.H.P.M., Inc. · KHE Reagent, Occult Blood
Cleared on Aug 12, 2004 after a 97-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 12, 2004
- Review
- 97 days
- Class
- Class II
- Product code
- KHE
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK041202 Hemosure One-Step Fecal Occult Blood TestW.H.P.M., Inc. · 2004
- Descendant · cites it directly · 0 of its ownK063693 Forsure One Step Fecal Occult Blood (Fob) Screen Card TestNew Bay Bioresearch Co., Ltd. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K063693Forsure One Step Fecal Occult Blood (Fob) Screen Card TestNew Bay Bioresearch Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041202 | Hemosure One-Step Fecal Occult Blood Test | W.H.P.M., Inc. | 2004 | — |
| +1 | K063693 | Forsure One Step Fecal Occult Blood (Fob) Screen Card Test | New Bay Bioresearch Co., Ltd. | 2007 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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 KHE? 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? (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 |
|---|---|---|---|
| * | — | Instant-View Fecal Occult Blood (FOB) II Test (Cassette) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063693 | Forsure One Step Fecal Occult Blood (Fob) Screen Card Test | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2019 | Class III | Z-1080-2019 | No Marketing Application | Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063693 (New Bay Bioresearch Co., Ltd., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KHE devicesKHE Reagent, Occult Blood: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHE
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KHE
126in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHE
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHE
3in 2025
MAUDE reports naming product code KHE, 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 | 3 | 104 | 0 | 3 |
| 2008 | 3 | 93 | 1 | 5 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 2 | — | 6 | 4 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 0 | — | 2 | 16 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 1 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 4 | 126 | 0 | 1 |
| 2018 | 1 | — | 1 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hemosure™ One-Step Fecal Occult Blood (FOB) Test is an immunochemical device
intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians
offices. It is useful to determine gastrointestinal (GI) bleeding found in a number of GI
disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041202: Hemosure One-Step Fecal Occult Blood Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041202
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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