510(k) · Cleared
Recalled · Class II · 2013Hemoccult Ict
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · KHE Reagent, Occult Blood
Cleared on Jun 25, 2008 after a 93-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 25, 2008
- Review
- 93 days
- Class
- Class II
- Product code
- KHE
- Recalls
- 2
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK080812 Hemoccult IctBeckman Coulter, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK101831 Enterix Insurefit Fob Controls, Model 16800Bionostics, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101831Enterix Insurefit Fob Controls, Model 16800Bionostics, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080812 | Hemoccult Ict | Beckman Coulter, Inc. | 2008 | — |
| +1 | K101831 | Enterix Insurefit Fob Controls, Model 16800 | Bionostics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K910666 | FDA’s K910666 is Vitek Anaerobe Identification Card, Modification Our reading of the summary gave K910666, FDA’s number for Vitek Anaerobe Identification Card, Modification (Vitek Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hemoccult ICT (formerly FlexSure OBT)”. Kept off the family tree. | 1991 |
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 |
|---|---|---|---|
| K101831 | Enterix Insurefit Fob Controls, Model 16800 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2013 | Class II | Z-1997-2013 | Under Investigation by firm | Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirmed an increase in sensitivity at the… |
| Jul 16, 2013 | Class II | Z-2197-2013 | Storage | The products may have been stored at temperatures outside their required storage conditions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101831 (Bionostics, Inc., 2010) has gone furthest, with 0 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. 2008, 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?
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. Fecal occult blood tests are useful screening aids for detecting primarily lower gastrointentinal (g.i.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Hemoccult ICT is recommended for use by health professionals as part of routine physical examinations or when lower g.i. disorders are suspected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080812: Hemoccult Ict.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080812
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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