510(k) · Cleared
ClearedInstant-view-PLUS immunochemical Fecal Occult Blood 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 Feb 15, 2018 as substantially equivalent to K070660 (Alfa Scientific Designs, Inc., 2007) and 1 other predicate after a 136-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Feb 15, 2018
- Review
- 136 days
- Class
- Class II
- Product code
- KHE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K880499 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK880499 Hemoccult Sensitive TestSmithkline Diagnostics, Inc. · 1988
- 1 generation backK021423 Instant-View Fecal Occult Blood Rapid TestAlfa Scientific Designs, Inc. · 2002
- This deviceK173212 Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880499 | Hemoccult Sensitive Test | Smithkline Diagnostics, Inc. | 1988 | — |
| −1 | K021423 | Instant-View Fecal Occult Blood Rapid Test | Alfa Scientific Designs, Inc. | 2002 | — |
| 0 (this device) | K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018 | — |
Other ancestors 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? (2)
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 |
|---|---|---|---|
| * | K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestSummary page 4…Classification Name: Occult Blood Test Classification: Class II Product Code: KHE Predicate Device: K070660 and K021423 Device Description: This device is a Driven Flow™ chromatographic immunoassay consisting of a test strip housed in a… | 2007 |
| * | K021423 | Instant-View Fecal Occult Blood Rapid TestSummary page 4…Classification Name: Occult Blood Test Classification: Class II Product Code: KHE Predicate Device: K070660 and K021423 Device Description: This device is a Driven Flow™ chromatographic immunoassay consisting of a test strip housed in a plastic cas… | 2002 |
| † | K101831 | Enterix Insurefit Fob Controls, Model 16800 | 2010 |
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?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K070660.
How does its category compare?
All KHE devicesKHE Reagent, Occult Blood: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Instant-view-plus™ Immunochemical Fecal Occult Blood Test is a qualitative immunoassay for detection of Fecal Occult Blood. It is intended for professional and over the counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173212: Instant-view-PLUS immunochemical Fecal Occult Blood Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173212
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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