510(k) · Cleared
Recalled · Class II · 2021Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delta Med Srl · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 28, 2012 as substantially equivalent to K072419 (Smiths Medical Asd, Inc., 2007) and 1 other predicate after a 269-day review. Its family tree reaches back 2 generations to 1980. It has been recalled 6 times.
- Decided
- Dec 28, 2012
- Review
- 269 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801941 (1980). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 1 generation backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- This deviceK121007 Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1…Delta Med Srl · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −1 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| 0 (this device) | K121007 | Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta… | Delta Med Srl | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 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 |
|---|---|---|---|
| * | K072419 | Advantiv Safety I.V. CatheterSummary page 3…with predicate devices: The predicate devices selected for comparison with the Neo Delta Self Safe IV Catheters are: Predicate device 1 (PD 1): Smiths Medical Advantiv K072419 Predicate device 2 (PD 2): B. Braun Introcan Safety IV Catheter K982805 The subject device and the two predicate devices all have… | 2007 |
| * | K982805 | Introcan Safety IV CatheterSummary page 3…ith the Neo Delta Self Safe IV Catheters are: Predicate device 1 (PD 1): Smiths Medical Advantiv K072419 Predicate device 2 (PD 2): B. Braun Introcan Safety IV Catheter K982805 The subject device and the two predicate devices all have a safety feature system to prevent needlestick injuries that is am inte… | 1999 |
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 |
|---|---|---|---|---|
| Jun 21, 2021 | Class II | Z-2301-2021 | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
| Jun 21, 2021 | Class II | Z-2300-2021 | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
| Jun 21, 2021 | Class II | Z-2302-2021 | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
| Jun 21, 2021 | Class II | Z-2303-2021 | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
| Jun 21, 2021 | Class II | Z-2304-2021 | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
| Jun 21, 2021 | Class II | Z-2299-2021 | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
Neo Delta Self Safe Catheters are intravascular catheters intended for short term use for the intravenous administration of fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121007: Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121007
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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