510(k) · Cleared
ClearedHema Screen ER
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunostics Inc., · KHE Reagent, Occult Blood
Cleared on Jan 28, 2011 after a 135-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 28, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- KHE
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK102664 Hema Screen ERImmunostics Inc., · 2011
- Descendant · cites it directly · 0 of its ownK163554 hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc., · 2017
Most influential descendants
Showing 1 of 1 · See all- K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc., · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102664 | Hema Screen ER | Immunostics Inc., | 2011 | — |
| +1 | K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | Immunostics Inc., | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood 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?
- Of its descendants, K163554 (Immunostics Inc.,, 2017) 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. 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?
hema-screenTm ER is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K102664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102664: Hema Screen ER.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102664
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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