510(k) Report

510(k) · Cleared

Cleared

Saliva Sampler

K942435510(k) TraditionalCleared Aug 21, 1995458-day reviewClass II21 CFR 862.1675

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Saliva Diagnostic Systems, Inc. · PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Cleared on Aug 21, 1995 after a 458-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Aug 21, 1995
Review
458 days
Class
Class II
Product code
PJD
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2019: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared1995200020052010201520202025
  1. This deviceK942435 Saliva SamplerSaliva Diagnostic Systems, Inc. · 1995
  2. Descendant · cites it directly · 3 of its ownK183048 Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation · 2019
  3. Descendant · 2 generations on · 1 of its ownK200801 Quantisal Oral Fluid Collection DeviceImmunalysis Corporation · 2020
  4. Descendant · cites it directly · 1 of its ownK984361 Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 1999 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK232898 Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation · 2023
  6. Descendant · 2 generations on · 0 of its ownK223781 Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1999: 22019: 12020: 12023: 2
1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all
  • K183048Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation · 2019 · cites it directly3descendants
  • K200801Quantisal Oral Fluid Collection DeviceImmunalysis Corporation · 2020 · 2 generations on1descendant
  • K984361Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 1999 · cites it directly1descendant
  • K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation · 2023 · 3 generations on0descendants
  • K223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942435Saliva SamplerSaliva Diagnostic Systems, Inc.1995—
+1K183048Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation2019—
+2K200801Quantisal Oral Fluid Collection DeviceImmunalysis Corporation2020—
+1K984361Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc.19991
+3K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation2023—
+2K223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
201910
202010
202320
FIG. 1 — Lineage of K942435, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K232898 Quantisal™ Oral Fluid Collection Devicescore 7.0 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K183048Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation20193
K984361Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc.19991

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, K183048 (Immunalysis Corporation, 2019) has gone furthest, with 3 descendants of its own.

How does its category compare?

All PJD devices

PJD 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

2019: 12020: 12023: 2
2007high 2 (2023) · low 0 (2007)2026

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

2016: 12017: 12019: 12020: 32022: 12023: 22024: 12025: 1
2007high 3 (2020) · low 0 (2007)2025

MAUDE reports naming product code PJD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—01
20180—00
20191—01
20201—03
20210—00
20220—01
20232—02
20240—01
20250—01
20260—0—

More from Saliva Diagnostic Systems, Inc.

2 FDA decisions under this applicant name. See the company

  • K980782Stat-Simple PyloriSaliva Diagnostic Systems, Inc. · 1998

Recent decisions in PJD

The PJD category page

  • K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation · 2023
  • K223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation · 2023
  • K200801Quantisal Oral Fluid Collection DeviceImmunalysis Corporation · 2020
  • K183048Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation · 2019
  • K011057Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXOraSure Technologies, Inc. · 2001

https://510kreport.com/device/K942435 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942435: Saliva Sampler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942435

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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