510(k) · Cleared
ClearedPhysician Industries' Durameter Syringe
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 Jul 12, 2004 as substantially equivalent to K913994 (Merit Medical Systems, Inc., 1992) and 3 other predicates after a 227-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Jul 12, 2004
- Review
- 227 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K904954 (1991). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904954 Condor Digital Inflation SyringeProfessional Medical Services · 1991
- This deviceK033739 Physician Industries' Durameter SyringePhysician Industries, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK102192 Indiscal Digital ManometerBaylis Medical Co., Inc. · 2011
- Descendant · cites it directly · 0 of its ownK050753 Stryker DiscmonitorStryker Instruments · 2005
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 |
|---|---|---|---|---|---|
| −1 | K904954 | Condor Digital Inflation Syringe | Professional Medical Services | 1991 | — |
| 0 (this device) | K033739 | Physician Industries' Durameter Syringe | Physician Industries, Inc. | 2004 | — |
| +1 | K102192 | Indiscal Digital Manometer | Baylis Medical Co., Inc. | 2011 | — |
| +1 | K050753 | Stryker Discmonitor | Stryker Instruments | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 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 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? (4)
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 |
|---|---|---|---|
| * | K913994 | Monarch (TM) Inflation SyringeSummary page 1…II (all) Classification~ IZO Regulation Nos.: 892-1730 02- PREDICATE DEVICES: * Balloon Inflation Syringe, cleared under K913994 (Feb 04, 1992); Similar controls, software, and materials. Different intended use- * Digital In… | 1992 |
| * | K904954 | Condor Digital Inflation SyringeSummary page 1…(Feb 04, 1992); Similar controls, software, and materials. Different intended use- * Digital Intlation Device (syringe), cleared under [K904954 (Jan 16, 1991); Similar controls, software, and materials- Different intended use. • Discograph… | 1991 |
| * | K960082 | Discography KitSummary page 1…ared under [K904954 (Jan 16, 1991); Similar controls, software, and materials- Different intended use. • Discography Kit, cleared under K960082 (Mar 21, 1996); different material same intended use- * Discography Kit, cleared under K910503… | 1996 |
| * | K910503 | Discography KitSummary page 1…• Discography Kit, cleared under K960082 (Mar 21, 1996); different material same intended use- * Discography Kit, cleared under K910503 (Oct 07,1L991), different material same intended use. All determined to be SE. 03. DESCRIPTION: The Physi… | 1991 |
What descends from it? (2)
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?
- None of the 4 ancestors has a recall.
- Of its descendants, K102192 (Baylis Medical Co., Inc., 2011) has gone furthest, with 0 descendants of its own.
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) | — |
What is it indicated for?
For use in diagnosis of herniated or otherwise diseased intervertebral disks in the human spine. This device has not been evaluated for use in vertebroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033739 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033739: Physician Industries' Durameter Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033739
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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