510(k) · Cleared
Recalled · 2011Oral-Eze Oral Fluid Collection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osborn Laboratories, Inc. · PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Cleared on Jan 13, 1999 as substantially equivalent to K942435 (Saliva Diagnostic Systems, Inc., 1995) and 2 other predicates after a 37-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 13, 1999
- Review
- 37 days
- Class
- Class II
- Product code
- PJD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970357 (1997). 3 ancestors in all, the oldest K942435 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970357 EpiscreenEpitope, Inc. · 1997
- 1 generation backK973395 Episcreen Oral Specimen Collection DeviceEpitope, Inc. · 1998
- This deviceK984361 Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK991800 Hemochek Urine Collection KitOsborn Group, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K991800Hemochek Urine Collection KitOsborn Group, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970357 | Episcreen | Epitope, Inc. | 1997 | — |
| −1 | K973395 | Episcreen Oral Specimen Collection Device | Epitope, Inc. | 1998 | — |
| 0 (this device) | K984361 | Oral-Eze Oral Fluid Collection System | Osborn Laboratories, Inc. | 1999 | — |
| +1 | K991800 | Hemochek Urine Collection Kit | Osborn Group, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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? (3)
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 |
|---|---|---|---|
| * | K942435 | Saliva Sampler Our OCR of the scanned summary read K842435, FDA’s number for Model T 101 Clinical Transmitter (Biometric Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Saliva-Sampler® Saliva Collection Device”. | 1995 |
| * | K973395 | Episcreen Oral Specimen Collection DeviceSummary page 1…ice), cleared for commercial distribution per K842435, and to the EpiScreen™ Oral Collection Device (secondary predicate device), cleared for commercial distribution per K973395 and K970357. Device Description: The Oral-Eze Oral Fluid Collection System is a device used by a person under the supervision o… | 1998 |
| * | K970357 | EpiscreenSummary page 1…d for commercial distribution per K842435, and to the EpiScreen™ Oral Collection Device (secondary predicate device), cleared for commercial distribution per K973395 and K970357. Device Description: The Oral-Eze Oral Fluid Collection System is a device used by a person under the supervision of a trained… | 1997 |
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 |
|---|---|---|---|
| K991800 | Hemochek Urine Collection Kit | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2011 | Not classified | Z-1101-2012 | Device Design | Low buffer fill volumes on Oral-Eze, an oral fluid collection system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K991800 (Osborn Group, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K942435.
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?
The Oral-Eze Oral Fluid Collection System is a prescription device, intended for use by a person under the supervision of a trained health care professional to collect oral fluid specimens, contain these specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.
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/K984361 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984361: Oral-Eze Oral Fluid Collection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984361
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