510(k) · Cleared
ClearedExelint Aluminum Hub Blunt Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exelint International, Co. · LHI Set, I.V. Fluid Transfer
Cleared on Oct 20, 2010 as substantially equivalent to K854547 (Sherwood Medical Co., 1986) after a 163-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Oct 20, 2010
- Review
- 163 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854547 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK854547 Monoject Sterile M200 Aluminum/M250 PolypropyleneSherwood Medical Co. · 1986 · Recalled
- This deviceK101309 Exelint Aluminum Hub Blunt NeedlesExelint International, Co. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854547 | Monoject Sterile M200 Aluminum/M250 Polypropylene | Sherwood Medical Co. | 1986 | 18 |
| 0 (this device) | K101309 | Exelint Aluminum Hub Blunt Needles | Exelint International, Co. | 2010 | — |
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 LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 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 |
|---|---|---|---|
| * | K854547 | Monoject Sterile M200 Aluminum/M250 PolypropyleneSummary page 1…ially equivalent to the MONOJECT® Rigid Pack Blunt Cannula, cleared as the Monoject Sterile M200 Aluminum Hub Blunt Cannula Device under 510(k) file number K854547. 1.8 Technological Characteristics The EXELINT Aluminum Hub Blunt Needles are constructed of the same materials… | 1986 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K854547.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The EXELINT Aluminum Hub Blunt Needles are intended to be used in a variety of medical, pharmaceutical and laboratory procedures to extract fluid or medication from vials or ampoule for transfer or for irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101309: Exelint Aluminum Hub Blunt Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101309
Report an extraction error
Are you the manufacturer?
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