510(k) · Cleared
ClearedHarvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barnstead/Thermolyne Corp. · FLE Sterilizer, Steam
Cleared on Feb 22, 2002 as substantially equivalent to K924955 (Mdt Corp., Inc., 1993) after a 64-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Feb 22, 2002
- Review
- 64 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924955 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK924955 MDT/Harvey MC-8 and MC-10Mdt Corp., Inc. · 1993
- This deviceK014174 Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33Barnstead/Thermolyne Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924955 | MDT/Harvey MC-8 and MC-10 | Mdt Corp., Inc. | 1993 | — |
| 0 (this device) | K014174 | Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33 | Barnstead/Thermolyne Corp. | 2002 | — |
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 |
|---|---|---|---|
| * | K924955 | MDT/Harvey MC-8 and MC-10Summary page 1…t-line Extension [] Initial Import into the USA (] Other (Include in Part IV an explanation referenced to Part I. H.) Predicate Device: Harvey® MC10 Steam Sterilizer, K924955 Description of the Device: The Harvey® PV Dry is a pre/post-vacuum table top steam sterilizer. Its enclosure is m… | 1993 |
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.
What does this lineage say?
- Its one ancestor has no recall.
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 Harvey® PV Dry is a prevacuum and post vacuum drying sterilizer intended to provide sterilization of medical and dental instruments. It is intended to provide sterilization of wrapped or unwrapped metal instruments, surgical devices and other heat stable devices in pouches, surgical packs, dental handpieces, and linen packs. Deionized or distilled water is required for operation of the Harvey® PV Dry. The sterilizer has four standard cycles…
Read the full statement (118 words)
The Harvey® PV Dry is a prevacuum and post vacuum drying sterilizer intended to provide sterilization of medical and dental instruments. It is intended to provide sterilization of wrapped or unwrapped metal instruments, surgical devices and other heat stable devices in pouches, surgical packs, dental handpieces, and linen packs. Deionized or distilled water is required for operation of the Harvey® PV Dry.
The sterilizer has four standard cycles: Unwrapped Instruments (135C for 3 minutes); Wrapped Instrumeats (135C for five minutes); Packs (121C for 30 minute); Special, for dental handpieces (5 minutes at 134C). There is also an accessible Bowie-Dick test cycle for routine testing of the steam penetration capability into packs. The parameters are fixed for each cycle.
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/K014174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014174: Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014174
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026