510(k) · Cleared
Recalled · Class II · 2018Profi Disposable Syringe, Profi Disposable Needle, DM Ject Insulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shinchang Medical Co., Ltd. · FMF Syringe, Piston
Cleared on Feb 25, 2000 after a 170-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Feb 25, 2000
- Review
- 170 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 8
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK993017 Profi Disposable Syringe, Profi Disposable Needle, DM Ject Insulin…Shinchang Medical Co., Ltd. · 2000
- Descendant · cites it directly · 1 of its ownK123710 Unitox Botox SyringeBio-Med USA, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK212677 aboNT SYRINGENipro Medical Corporation · 2022
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 |
|---|---|---|---|---|---|
| 0 (this device) | K993017 | Profi Disposable Syringe, Profi Disposable Needle, DM Ject Insulin Syringe | Shinchang Medical Co., Ltd. | 2000 | — |
| +1 | K123710 | Unitox Botox Syringe | Bio-Med USA, Inc. | 2013 | — |
| +2 | K212677 | aboNT SYRINGE | Nipro Medical Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 16.1 · 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K123710 | Unitox Botox Syringe | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2018 | Class II | Z-0119-2019 | Equipment maintenance | Small hole at the end of the syringe is impeding suction of liquid. |
| Aug 24, 2018 | Class II | Z-3202-2018 | Under Investigation by firm | Defect consists of a small crack in the top end of the barrel near the needle. |
| Oct 27, 2009 | Not classified | Z-0573-2010 | Other | Needles are becoming dislodged from the barrels. |
| Oct 27, 2009 | Not classified | Z-0570-2010 | Other | Needles are becoming dislodged from the barrels. |
| Oct 27, 2009 | Not classified | Z-0571-2010 | Other | Needles are becoming dislodged from the barrels. |
| Oct 27, 2009 | Not classified | Z-0574-2010 | Other | Needles are becoming dislodged from the barrels. |
| Oct 27, 2009 | Not classified | Z-0569-2010 | Other | Needles are becoming dislodged from the barrels. |
| Oct 27, 2009 | Not classified | Z-0572-2010 | Other | Needles are becoming dislodged from the barrels |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123710 (Bio-Med USA, Inc., 2013) has gone furthest, with 1 descendant 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?
Hypodermic single lumen needle: Device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Piston Syringe: Device is used to inject fluids into, or withdraw fluids from the body.
Diabetic Insulin Syringe: Device intended to inject insulin below the surface of the skin.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993017: Profi Disposable Syringe, Profi Disposable Needle, DM Ject Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993017
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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