510(k) · Cleared
Recalled · 2011Forsure One Step Fecal Occult Blood (Fob) Screen Card Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Bay Bioresearch Co., Ltd. · KHE Reagent, Occult Blood
Cleared on May 11, 2007 as substantially equivalent to K041202 (W.H.P.M., Inc., 2004) after a 149-day review. Its family tree reaches back 1 generation to 2004. It has been recalled 4 times.
- Decided
- May 11, 2007
- Review
- 149 days
- Class
- Class II
- Product code
- KHE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041202 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041202 Hemosure One-Step Fecal Occult Blood TestW.H.P.M., Inc. · 2004 · Recalled
- This deviceK063693 Forsure One Step Fecal Occult Blood (Fob) Screen Card TestNew Bay Bioresearch Co., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041202 | Hemosure One-Step Fecal Occult Blood Test | W.H.P.M., Inc. | 2004 | 1 |
| 0 (this device) | K063693 | Forsure One Step Fecal Occult Blood (Fob) Screen Card Test | New Bay Bioresearch Co., Ltd. | 2007 | — |
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 |
|---|---|---|---|
| * | K041202 | Hemosure One-Step Fecal Occult Blood TestSummary page 2…e Devices: Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is substantially equivalent to WHPM Hemosure One Step Fecal Occult Blood (FOB) Test cleared by FDA (K041202) for its stated intended use. Device Description: Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a qualitative, s… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2011 | Not classified | Z-2110-2011 | Other | Potential for false negatives test results and negative/faint positive controls |
| Mar 21, 2011 | Not classified | Z-2108-2011 | Other | Potential for false negatives test results and negative/faint positive controls |
| Mar 21, 2011 | Not classified | Z-2111-2011 | Other | Potential for false negatives test results and negative/faint positive controls |
| Mar 21, 2011 | Not classified | Z-2109-2011 | Other | Potential for false negatives test results and negative/faint positive controls |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All KHE devicesKHE Reagent, Occult Blood: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid,
immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin)
in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult
blood, which may be indicative of gastrointestinal disease associated with bleeding such as
colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is an immunological test for both
professional and over the counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063693 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063693: Forsure One Step Fecal Occult Blood (Fob) Screen Card Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063693
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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