510(k) · Cleared
ClearedISP Safety Huber Needle Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infusion Safety Products, Inc. · PTI Non-Coring (Huber) Needle
Cleared on Dec 14, 2017 as substantially equivalent to K993848 (Millennium Medical Distribution, Inc., 2000) after a 265-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Dec 14, 2017
- Review
- 265 days
- Class
- Class II
- Product code
- PTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890127 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
- 1 generation backK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
- This deviceK170881 ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890127 | Intravascular Administration Set | Multi-Med, Inc. | 1989 | — |
| −1 | K993848 | Millennium Huber Plus Safety Infusion Set | Millennium Medical Distribution, Inc. | 2000 | 2 |
| 0 (this device) | K170881 | ISP Safety Huber Needle Infusion Set | Infusion Safety Products, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1991 | 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 PTI? 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 PTI device
- #1 K254095 25G Huber Needlescore 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K993848 | Millennium Huber Plus Safety Infusion SetSummary page 5…510(k) Summary 5. Legally Marketed Predicate Device(s) K993848 - Millennium Huber Plus Safety Infusion Set, Millennium Medical Distribution, Inc. 6. Indication for Use Statement The ISP S… | 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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 6 other devices also cite its predicate K993848.
How does its category compare?
All PTI devicesPTI Non-Coring (Huber) Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PTI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTI
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PTI
No recall names PTI since 2007.
Adverse event reports per year · PTI
33in 2025
MAUDE reports naming product code PTI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 5 | 221 | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 2 | — | 0 | 17 |
| 2022 | 1 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 1 | — | 0 | 36 |
| 2025 | 3 | 120 | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient’s surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle by encapsulating the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170881: ISP Safety Huber Needle Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170881
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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