510(k) · Cleared
ClearedHarmac Huber Needle Safety Device, H2984001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harmac Medical Products, Inc. · FPA Set, Administration, Intravascular
Cleared on Aug 29, 2002 as substantially equivalent to K950895 (Harmac Medical Products, Inc., 1995) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 1976.
- Decided
- Aug 29, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K760733 (1976). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK760733 Skin Staple ExtractorETHICON, Inc. · 1976
- 2 generations backK955748 Doyle ExtractorSafetech Intl., Inc. · 1996
- 1 generation backK973497 HuberlocMedcare Medical Group, Inc. · 1998
- This deviceK021916 Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K760733 | Skin Staple Extractor | ETHICON, Inc. | 1976 | — |
| −2 | K955748 | Doyle Extractor | Safetech Intl., Inc. | 1996 | — |
| −1 | K973497 | Huberloc | Medcare Medical Group, Inc. | 1998 | — |
| 0 (this device) | K021916 | Harmac Huber Needle Safety Device, H2984001 | Harmac Medical Products, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K950895 | Harmac Extension Infusion SetSummary page 1…Harmac Huber Needle Safety Device Classification Name: IV Administration SeVAccessory 3. Identification of Predicate Devices: 51O(k) Number: K950895 Trade Name: Huber Needle Infusion Set Regulatory Class: II Product Code: FPA Harmac Medical Products,… | 1995 |
| * | K973497 | HuberlocSummary page 1…er: K950895 Trade Name: Huber Needle Infusion Set Regulatory Class: II Product Code: FPA Harmac Medical Products, Inc. 51O(k) Number: K973497 Trade Name: Huberloc Regulatory Class: Unclassified Product Code: LJT MedCare Medical Group, Inc.… | 1998 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The intended use of this device is for the removal of 90 degree winged infusion
sets, manufactured by Harmac Medical Products and having a 1-1/2" needle or
shorter, from implanted ports and the containment of the used needle until placed
in an appropriate sharps container. When used in this manner this device is
intended to aid in the prevention of needle stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021916 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021916: Harmac Huber Needle Safety Device, H2984001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021916
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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