510(k) · Cleared
ClearedPrimus Steam Sterilizers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primus Sterilizer Co., Inc. · FLE Sterilizer, Steam
Cleared on Dec 3, 1999 after a 211-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Dec 3, 1999
- Review
- 211 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK991575 Primus Steam SterilizersPrimus Sterilizer Co., Inc. · 1999
- Descendant · cites it directly · 3 of its ownK082817 Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-MPrimus Sterilizer Company, LLC · 2009
- Descendant · cites it directly · 2 of its ownK093333 Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional…Primus Sterilizer Company, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK221474 PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK233132 PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K082817Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-MPrimus Sterilizer Company, LLC · 2009 · cites it directly3descendants
- K093333Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO…Primus Sterilizer Company, LLC · 2010 · cites it directly2descendants
- K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023 · 2 generations on1descendant
- K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991575 | Primus Steam Sterilizers | Primus Sterilizer Co., Inc. | 1999 | — |
| +1 | K082817 | Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-M | Primus Sterilizer Company, LLC | 2009 | — |
| +1 | K093333 | Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO… | Primus Sterilizer Company, LLC | 2010 | — |
| +2 | K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023 | — |
| +3 | K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2023 | 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 FLE? 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 FLE device
- #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K082817 (Primus Sterilizer Company, LLC, 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, 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 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
What is it indicated for?
The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are avallablc in the following configurations: 13” x 13" x 23" Multi-Functional Sterilizer 13" X 13" x 23" Laboratory/Lo 16” x 16" x 26” Multi-Functional…
Read the full statement (225 words)
The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are avallablc in the following configurations:
13” x 13" x 23" Multi-Functional Sterilizer
13" X 13" x 23" Laboratory/Lo
16” x 16" x 26” Multi-Functional Sterilizer
16” x 16” x 26” Laboratory/Lo
20” x 20” x 38" Multi-Functional Sterilizer
20” x 20” x 38” Laboratory/Lo
26” x 26” x 39” Multi-Functional Sterilizer
26” x 26” x 39" Laboratory/Lo
26" x 26” x 49” Multi-Functional Sterilizer
26" x 26" x 49" Laburatory/Lo
26” x 26” x 67” Multi-Functional Sterilizer
26” x 26” x 67” Laboratory/Lo
26" x 36™ x 39" Multi-Functional Sterilizer
26” x 36” x 39” Laboratory/Lo
26" x 36™ x 48" Multi-Functional Sterilizer
26” x 36” x 48" Laboratory/Lo
26" x 36" x 60” Multi-Functional Sterilizer
26 x 36" x 60" Laboratory/Lo
26” x 63” x 48" Multi-Functional Sterilizer
26" x 63" x 48" Laboratory/Lo
26" x 63” x 76" Multi-Functional Sterilizer
26" x 63" x 76" Laboratory/Lo
Sterilizers are available in Multifunctional models which includes vacuum and gravity cycles and Laboratory/Lo-Temperature models which includes the vacuum and gravity cycles as well as a low temperature feature for pasteurization and sterilization processes.
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/K991575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991575: Primus Steam Sterilizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991575
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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