510(k) · Cleared
ClearedInstant-View Fecal Occult Blood Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · KHE Reagent, Occult Blood
Cleared on Jun 17, 2002 as substantially equivalent to K880499 (Smithkline Diagnostics, Inc., 1988) after a 45-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.
- Decided
- Jun 17, 2002
- Review
- 45 days
- Class
- Class II
- Product code
- KHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880499 (1988). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK880499 Hemoccult Sensitive TestSmithkline Diagnostics, Inc. · 1988
- This deviceK021423 Instant-View Fecal Occult Blood Rapid TestAlfa Scientific Designs, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK173212 Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK121397 Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit…SEKISUI Diagnostics, LLC · 2012
- Descendant · cites it directly · 0 of its ownK060953 Occultech Fecal Occult Blood Rapid TestYd Diagnostics Corp. · 2006
Most influential descendants
Showing 3 of 3 · See all- K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018 · cites it directly0descendants
- K121397Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitSEKISUI Diagnostics, LLC · 2012 · cites it directly0descendants
- K060953Occultech Fecal Occult Blood Rapid TestYd Diagnostics Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880499 | Hemoccult Sensitive Test | Smithkline Diagnostics, Inc. | 1988 | — |
| 0 (this device) | K021423 | Instant-View Fecal Occult Blood Rapid Test | Alfa Scientific Designs, Inc. | 2002 | — |
| +1 | K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018 | — |
| +1 | K121397 | Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob… | SEKISUI Diagnostics, LLC | 2012 | — |
| +1 | K060953 | Occultech Fecal Occult Blood Rapid Test | Yd Diagnostics Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K880499 | Hemoccult Sensitive TestSummary page 1…3) screening for colorectal cancer or gastrointestinal bleeding &om any source. VIII. Predicate Product: HemoccultB test by Beckman Coulter, Inc., 5 1OK# K880499. IX. Performance Summary: The Imtant-ViewTMFOB Rapid Test is more accurate than the predicate device HemoccultB. The… | 1988 |
What descends from it? (3)
3 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?
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?
This Fecal Occult Blood (FOB) Rapid Test is an immunochemical device intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians offices. It is useful to determining gastrointestinal (GI) bleeding found in a number of gastrointestinal (GI) disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.
This test is recommended for use in 1) routine physical examinations, when hospital patients are first admitted, 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021423 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021423: Instant-View Fecal Occult Blood Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021423
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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