510(k) · Cleared
ClearedHemoccult Sensitive Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smithkline Diagnostics, Inc. · KHE Reagent, Occult Blood
Cleared on May 23, 1988 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 23, 1988
- Review
- 108 days
- Class
- Class II
- Product code
- KHE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK880499 Hemoccult Sensitive TestSmithkline Diagnostics, Inc. · 1988
- Descendant · cites it directly · 3 of its ownK070660 Instant-View Fecal Occult Blood (Fob) Rapid TestAlfa Scientific Designs, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK021423 Instant-View Fecal Occult Blood Rapid TestAlfa Scientific Designs, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK110309 Fob One Step Rapid TestOrient Gene Biotech · 2011
- Descendant · 2 generations on · 0 of its ownK173212 Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK162333 Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K070660Instant-View Fecal Occult Blood (Fob) Rapid TestAlfa Scientific Designs, Inc. · 2007 · cites it directly3descendants
- K021423Instant-View Fecal Occult Blood Rapid TestAlfa Scientific Designs, Inc. · 2002 · cites it directly3descendants
- K110309Fob One Step Rapid TestOrient Gene Biotech · 2011 · 2 generations on1descendant
- K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018 · 2 generations on0descendants
- K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880499 | Hemoccult Sensitive Test | Smithkline Diagnostics, Inc. | 1988 | — |
| +1 | K070660 | Instant-View Fecal Occult Blood (Fob) Rapid Test | Alfa Scientific Designs, Inc. | 2007 | — |
| +1 | K021423 | Instant-View Fecal Occult Blood Rapid Test | Alfa Scientific Designs, Inc. | 2002 | — |
| +2 | K110309 | Fob One Step Rapid Test | Orient Gene Biotech | 2011 | — |
| +2 | K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018 | — |
| +3 | K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
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, K070660 (Alfa Scientific Designs, Inc., 2007) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K880499 · printed Nov 4, 2026
Cite this page
510(k) Report. “K880499: Hemoccult Sensitive Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880499
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026