FDA product code KHE: Reagent, Occult Blood
KHE is the FDA product code for reagent, occult blood. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel. FDA has cleared 97 510(k) submissions under KHE, from 62 different applicants. The average 510(k) review took 135 days (median 111). FDA has posted 19 recalls for KHE devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Occult Blood |
| Device class | Class II |
| Regulation | 21 CFR 864.6550 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KHE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 135 |
| 2018 | 1 | 136 |
Compare with all 510(k) review times · Search every KHE clearance
Top KHE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 12 | 2000-11-27 |
| Immunostics Inc., | 5 | 2017-06-14 |
| Smithkline Diagnostics, Inc. | 4 | 1996-11-06 |
| Alfa Scientific Designs, Inc. | 3 | 2018-02-15 |
| Enterix, Inc. | 3 | 2017-10-05 |
57 more applicants have KHE clearances. See the full list in Caduvo.
Most recent KHE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173212 | Alfa Scientific Designs, Inc. | Instant-view-PLUS immunochemical Fecal Occult Blood Test | 2018-02-15 | 136 |
| K170548 | Enterix, Inc. | InSure ONE | 2017-10-05 | 223 |
| K171484 | Immunostics Inc., | hema-screen SPECIFIC Gold | 2017-06-14 | 23 |
| K162333 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo One Step Fecal Occult Blood (FOB) Test | 2017-05-14 | 265 |
| K163554 | Immunostics Inc., | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | 2017-01-17 | 29 |
Recalls for KHE devices
19 product recalls in 12 recall events; 3 initiated in the last five years and 5 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code KHE?
KHE is the FDA product code for reagent, occult blood. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel.
What device class is KHE?
Class II, regulation 21 CFR 864.6550. Typical premarket route: 510(k).
How long does a 510(k) take for product code KHE?
Across 97 cleared submissions the average was 135 days from receipt to decision (median 111).
Which companies have the most KHE clearances?
Helena Laboratories (12); Immunostics Inc., (5); Smithkline Diagnostics, Inc. (4); Alfa Scientific Designs, Inc. (3); Enterix, Inc. (3).
Have KHE devices been recalled?
Yes: 19 product recalls across 12 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code KHE
- Run a recall and safety report across every KHE manufacturer
- Watch product code KHE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times