510(k) · Cleared
ClearedHuberloc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcare Medical Group, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Jan 13, 1998 as substantially equivalent to K955748 (Safetech Intl., Inc., 1996) after a 120-day review. Its family tree reaches back 2 generations to 1976. 1 later device descends from it.
- Decided
- Jan 13, 1998
- Review
- 120 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K760733 (1976). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK760733 Skin Staple ExtractorETHICON, Inc. · 1976
- 1 generation backK955748 Doyle ExtractorSafetech Intl., Inc. · 1996
- This deviceK973497 HuberlocMedcare Medical Group, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK021916 Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K021916Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K760733 | Skin Staple Extractor | ETHICON, Inc. | 1976 | — |
| −1 | K955748 | Doyle Extractor | Safetech Intl., Inc. | 1996 | — |
| 0 (this device) | K973497 | Huberloc | Medcare Medical Group, Inc. | 1998 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LJT? 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 LJT device
- #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 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 |
|---|---|---|---|
| * | K955748 | Doyle ExtractorSummary page 1…ell Director of Research and Development (603)352-3230 ) Name of Device: HuberLoc™ Classification Name: Unknown (3) Identification of Predicate Devices: §10(k) Number K955748 Doyle Extractor Product Code: MSDX-12 Med Stream Medical, Inc. Streetsboro, OH 44241 (4) Description of Device Subject to Prem… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021916 | Harmac Huber Needle Safety Device, H2984001 | 2002 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 19.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K021916 (Harmac Medical Products, Inc., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LJT devicesLJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJT
182in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJT
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LJT
4,308in 2025
MAUDE reports naming product code LJT, 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 | 11 | 85 | 1 | 208 |
| 2008 | 7 | 119 | 2 | 161 |
| 2009 | 2 | — | 2 | 172 |
| 2010 | 2 | — | 19 | 207 |
| 2011 | 5 | 144 | 1 | 202 |
| 2012 | 2 | — | 2 | 153 |
| 2013 | 7 | 150 | 0 | 141 |
| 2014 | 2 | — | 0 | 143 |
| 2015 | 4 | 164 | 1 | 149 |
| 2016 | 3 | 182 | 0 | 135 |
| 2017 | 0 | — | 1 | 262 |
| 2018 | 0 | — | 1 | 878 |
| 2019 | 1 | — | 7 | 765 |
| 2020 | 1 | — | 0 | 959 |
| 2021 | 0 | — | 0 | 1,285 |
| 2022 | 0 | — | 1 | 1,334 |
| 2023 | 1 | — | 0 | 1,221 |
| 2024 | 1 | — | 0 | 1,896 |
| 2025 | 2 | — | 0 | 4,308 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The intended use of this device is for the removal of 90° winged infusion sets, THE GRIPPER™, and VasTack™, having a 1-1/2"' needle or shortet firom implanted ports and the containment of the used needje until placed in a sharps container.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973497: Huberloc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973497
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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