510(k) · Cleared
ClearedFob One Step Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orient Gene Biotech · KHE Reagent, Occult Blood
Cleared on Sep 14, 2011 as substantially equivalent to K070660 (Alfa Scientific Designs, Inc., 2007) after a 224-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Sep 14, 2011
- Review
- 224 days
- Class
- Class II
- Product code
- KHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K880499 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK880499 Hemoccult Sensitive TestSmithkline Diagnostics, Inc. · 1988
- 1 generation backK070660 Instant-View Fecal Occult Blood (Fob) Rapid TestAlfa Scientific Designs, Inc. · 2007
- This deviceK110309 Fob One Step Rapid TestOrient Gene Biotech · 2011
- Descendant · cites it directly · 0 of its ownK162333 Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd. · 2017 · cites it directly0descendants
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 | K070660 | Instant-View Fecal Occult Blood (Fob) Rapid Test | Alfa Scientific Designs, Inc. | 2007 | — |
| 0 (this device) | K110309 | Fob One Step Rapid Test | Orient Gene Biotech | 2011 | — |
| +1 | 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 |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestSummary page 1…Occult Blood Test. Regulation 21 CFR 864.6550 Classification Class 11 Product Codes KHE Panel: Hematology Predicate Device: K070660 - INSTANT-VIEVV# Fecal Occult Blood (FOB) Rapid Test Device Description The FOB One Step Rapid Test is a lateral flow chromato… | 2007 |
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 |
|---|---|---|---|
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | 2017 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 19.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162333 (Guangzhou Wondfo Biotech Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 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. 2011, 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 FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110309: Fob One Step Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110309
Report an extraction error
Are you the manufacturer?
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