510(k) · Cleared
ClearedSimplex Saliva Absorber/Collector, Model Ssa-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irt Management Corp. · KHR Absorber, Saliva, Paper
Cleared on Apr 21, 1998 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 21, 1998
- Review
- 50 days
- Class
- Class I
- Product code
- KHR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 KHR? 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?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All KHR devicesKHR Absorber, Saliva, Paper: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHR
FDA has decided no KHR device since 2007.
Median 510(k) review, days · KHR
Too few KHR 510(k)s in any year since 2007 to give a median.
Recalls per year · KHR
No recall names KHR since 2007.
Adverse event reports per year · KHR
1in 2019
MAUDE reports naming product code KHR, 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 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the absorption/Collection and removal of excessive saliva during dental procedures.
For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth.
For the absorption/Collection and removal of saliva in General Pediatric Use.
For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers.
For the absorption and removal of saliva when typical “suction” type devices are not appropriate or effective.
For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980783 · printed Nov 3, 2026
Cite this page
510(k) Report. “K980783: Simplex Saliva Absorber/Collector, Model Ssa-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K980783
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026