510(k) · Cleared
Recalled · Class II · 2015General Procedure Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physician Industries, Inc. · FMF Syringe, Piston
Cleared on Apr 12, 1996 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 33 times.
- Decided
- Apr 12, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 33
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2015 | Class II | Z-0193-2016 | Process control | Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed… |
| May 19, 2011 | Not classified | Z-2575-2011 | Nonconforming Material/Component | Kits contain protective wipes that may be contaminated with Bacillus cereus. |
| May 19, 2011 | Not classified | Z-2576-2011 | Nonconforming Material/Component | Kits contain protective wipes that may be contaminated with Bacillus cereus. |
| Jul 13, 2009 | Not classified | Z-2094-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2080-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2105-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2079-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2099-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2089-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2103-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2081-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2101-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2100-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2096-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2092-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2097-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2093-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2095-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2086-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2108-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2083-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2088-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2107-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2098-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2102-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2085-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2082-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2104-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2091-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2090-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2087-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Jul 13, 2009 | Not classified | Z-2106-2009 | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Mar 18, 2008 | Not classified | Z-1635-2008 | Nonconforming Material/Component | Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin. |
The 5 latest of 33 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
https://510kreport.com/device/K960248 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960248: General Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960248
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026