510(k) · Cleared
ClearedPrimus Steam Sterilizer, Models PSS5-G-1 and PSS5-M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primus Sterilizer Company, LLC · FLE Sterilizer, Steam
Cleared on May 21, 2009 as substantially equivalent to K991575 (Primus Sterilizer Co., Inc., 1999) after a 238-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- May 21, 2009
- Review
- 238 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991575 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK991575 Primus Steam SterilizersPrimus Sterilizer Co., Inc. · 1999
- This deviceK082817 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 3 of 3 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K991575 | Primus Steam Sterilizers | Primus Sterilizer Co., Inc. | 1999 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K991575 | Primus Steam SterilizersSummary page 1…ture stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under K991575 except for larger chamber sizes. The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with t… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093333 | Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO… | 2010 | 2 |
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 FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 PSS5 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PRIMUS PSS5 Steam Sterilizer Series are available in the following configurations: PSS5-G.1-M*** (32" x 36" x 48" Multi-Functional Sterilizer) Single or PSS5-G.1-L***…
Read the full statement (244 words)
The PRIMUS PSS5 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PRIMUS PSS5 Steam Sterilizer Series are available in the following configurations:
PSS5-G.1-M*** (32" x 36" x 48" Multi-Functional Sterilizer) Single or
PSS5-G.1-L*** (32" x 36" x 48" Laboratory/Lo) Double Door
PSS5-M-M*** (35" x 57" x 60" Multi-Function Sterilizer) Single or
PSS5-M-L*** (35" x 57" x 60" Laboratory/Lo) Double Door
Sterilizers are available both in multi-functional models which feature vacuum, gravity, liquids and test (VAC) cycles and Laboratory/Lo-Temperature Models.
The Laboratory/Low Temperature models feature a cycle for pasteurization and inspissation processes of items such as infant formula and other liquids requiring lower temperature sterilization. PRIMUS Sterilizer Company, LLC directions for use cautions this OPTION IS NOT RECOMMENDED FOR REPROCESSING ITEMS FOR DIRECT PATIENT CONTACT.
PRIJUS Sterilizer Company, LLC recommends that a suitable chemical indicator or biological challenge test be used on a periodic basis to test effectiveness of the sterilizer in accordance with health care facilities documented plan for monitoring SAL 106 performance.
The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard goods, and linens. The cycles to be cleared for each of the models listed above are found in the table below:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082817: Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082817
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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