510(k) · Cleared
ClearedSafe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdc Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Sep 20, 2002 as substantially equivalent to K013304 (Becton Dickinson Infusion Therapy Systems, Inc., 2002) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Sep 20, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K993191 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK993191 TFX Medical Introducer AssemblyTfx Medical, Inc. · 2000
- This deviceK022099 Safe-T-Peel Safety Needle/Introducer, Models 350-300 S…Hdc Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993191 | TFX Medical Introducer Assembly | Tfx Medical, Inc. | 2000 | — |
| 0 (this device) | K022099 | Safe-T-Peel Safety Needle/Introducer, Models 350-300 S… | Hdc Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K013304 | BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded IntroducerSummary page 2…cal Introducer Assembly (K993191). The Safe-T-Peel@Safety Needle/Introducer is sub stantria1 I:jr equivalent, to the previously cleared predicate device (K013304) with sharps injur3r prevention features because it h a s the same intended uses, similar principles of ope1'1-1t.1011, siiiiilar… | 2002 |
| * | K993191 | TFX Medical Introducer AssemblySummary page 1…l Autoguard Introducer Safety Needle with Shielded Ass e mbly Introducer Introducer (KO 13304) I (K993191) (K000665) Intended Use The Safe-T-Peel@Safety Needle Introducer is used to facilitate placement of a… | 2000 |
| * | K000665 | TFX Medical Safety Needle with IntroducerSummary page 1…Introducer Safety Needle with Shielded Ass e mbly Introducer Introducer (KO 13304) I (K993191) (K000665) Intended Use The Safe-T-Peel@Safety Needle Introducer is used to facilitate placement of a peripherally inserted… | 2000 |
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?
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K013304.
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.
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?
The Safety-T-Peel Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022099: Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022099
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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