510(k) · Cleared
ClearedNeedleSmart Professional (NS Pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Needlesmart Limited · MTV Sharps Needle Destruction Device
Cleared on Mar 25, 2021 as substantially equivalent to P120018 (Sharps Terminator, LLC, 2016) after a 241-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Mar 25, 2021
- Review
- 241 days
- Class
- Class II
- Product code
- MTV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P120018 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backP120018 Sharps TerminatorSharps Terminator, LLC · 2016
- This deviceK202073 NeedleSmart Professional (NS Pro)Needlesmart Limited · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P120018 | Sharps Terminator | Sharps Terminator, LLC | 2016 | — |
| 0 (this device) | K202073 | NeedleSmart Professional (NS Pro) | Needlesmart Limited | 2021 | — |
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 MTV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | P120018 | Sharps TerminatorSummary page 4…MTV Regulation Number 21 CFR 880.6210 Review Panel General Hospital 3. Predicate Device Sharps Terminator (approved under P120018). Note: A Sharps Needle Destruction Device is now regulated under Class 2 and requires a 510(k) submission. 4. Devi… | 2016 |
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 no recall.
How does its category compare?
All MTV devicesMTV Sharps Needle Destruction Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MTV
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MTV
Too few MTV 510(k)s in any year since 2007 to give a median.
Recalls per year · MTV
No recall names MTV since 2007.
Adverse event reports per year · MTV
No MAUDE report names MTV since 2007.
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 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NeedleSmart Professional (NS Pro) is a needle destruction device that is intended for use by individuals and healthcare professionals to safely destroy 21-25 gauge needles between 0.625 (%4") inches to 1.5 (12") inches i.e. approx. 1.6 cm to 3.8 cm. The device is for use in treatment settings such as treatment rooms, emergency/trauma rooms, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, Dental Offices, and Clinical Laboratories.
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/K202073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202073: NeedleSmart Professional (NS Pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202073
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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