510(k) · Cleared
ClearedPrimus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO Sterilizer,Primus Steam Sterilizer PSS8
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 Apr 2, 2010 as substantially equivalent to K991575 (Primus Sterilizer Co., Inc., 1999) and 1 other predicate after a 158-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it.
- Decided
- Apr 2, 2010
- Review
- 158 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991575 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK991575 Primus Steam SterilizersPrimus Sterilizer Co., Inc. · 1999
- 1 generation backK082817 Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-MPrimus Sterilizer Company, LLC · 2009
- This deviceK093333 Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional…Primus Sterilizer Company, LLC · 2010
- Descendant · cites it directly · 1 of its ownK221474 PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK233132 PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K093333 | Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO… | Primus Sterilizer Company, LLC | 2010 | — |
| +1 | K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023 | — |
| +2 | 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 |
|---|---|---|
| 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? (2)
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…ure stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under 1K991575 and K(082817. The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options off… | 1999 |
| * | K082817 | Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-MSummary page 1…erials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under 1K991575 and K(082817. The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options offered under th… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | 2023 | 1 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221474 (Primus Sterilizer Company, LLC, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K991575.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 PSS8 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PRIMUS PSS8 Steam Sterilizer Series are available in the following configurations: Sterilizers are available in multi-functional models which feature vacuum, gravity…
Read the full statement (157 words)
The PRIMUS PSS8 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PRIMUS PSS8 Steam Sterilizer Series are available in the following configurations:
Sterilizers are available in multi-functional models which feature vacuum, gravity, liquids and test (VAC) cycles.
PRIMUS 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 10~ 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/K093333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093333: Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO Sterilizer,Primus Steam Sterilizer PSS8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093333
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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