510(k) · Cleared
ClearedEpiscreen Oral Specimen Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epitope, Inc. · PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Cleared on Feb 13, 1998 as substantially equivalent to K970357 (Epitope, Inc., 1997) after a 176-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Feb 13, 1998
- Review
- 176 days
- Class
- Class II
- Product code
- PJD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970357 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970357 EpiscreenEpitope, Inc. · 1997
- This deviceK973395 Episcreen Oral Specimen Collection DeviceEpitope, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK984361 Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK991800 Hemochek Urine Collection KitOsborn Group, Inc. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970357 | Episcreen | Epitope, Inc. | 1997 | — |
| 0 (this device) | K973395 | Episcreen Oral Specimen Collection Device | Epitope, Inc. | 1998 | — |
| +1 | K984361 | Oral-Eze Oral Fluid Collection System | Osborn Laboratories, Inc. | 1999 | 1 |
| +2 | K991800 | Hemochek Urine Collection Kit | Osborn Group, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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 PJD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PJD device
- #1 K232898 Quantisal™ Oral Fluid Collection Devicescore 7.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K970357 | EpiscreenSummary page 2…e collection area to the laboratory. Classification This 510(k) contains a modification to the package insert of the EpiScreen Oral Specimen Collection Device (510(k) #970357). This product has been deemed a Class I device under the following classification: o Blood Specimen Collection Device (Class II… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984361 | Oral-Eze Oral Fluid Collection System | 1999 | 1 |
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?
How does its category compare?
All PJD devicesPJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PJD
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PJD
Too few PJD 510(k)s in any year since 2007 to give a median.
Recalls per year · PJD
No recall names PJD since 2007.
Adverse event reports per year · PJD
1in 2025
MAUDE reports naming product code PJD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EpiScreen is intended for use in the collection, preservation, and transport of oral specimens.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973395: Episcreen Oral Specimen Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973395
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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