510(k) · Cleared
ClearedPortex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · MIA Needle, Spinal, Short Term
Cleared on Jun 14, 2018 as substantially equivalent to K983858 (Sims Portex, Inc., 1999) after a 269-day review. Its family tree reaches back 2 generations to 1989. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 14, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- MIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K885277 (1989). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK885277 Spinal Anesthesia TrayPreferred Medical Products · 1989
- 1 generation backK983858 Spinal Anesthesia Needles and Introducer NeedlesSims Portex, Inc. · 1999
- This deviceK172800 Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex®…Smiths Medical Asd, Inc. · 2018
Class I recalls in this family
- K911202 Atraumatic Standard Sprotte Needle2 generations back · 1992
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885277 | Spinal Anesthesia Tray | Preferred Medical Products | 1989 | — |
| −1 | K983858 | Spinal Anesthesia Needles and Introducer Needles | Sims Portex, Inc. | 1999 | — |
| 0 (this device) | K172800 | Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil… | Smiths Medical Asd, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K983858 | Spinal Anesthesia Needles and Introducer NeedlesSummary page 4…ia conduction needle Regulatory Class II II Product Code MIA MIA 510(k) K983858 K172800 Reference device - K112515 – Pencan Spinal Needles, Spinocan Spinal Needles, Spinal Introdu… | 1999 |
| † | K112515 | Pencan Spinal Needle | 2011 |
| † | K141126 | Uniever Disposable Spinal Anesthesia Needle | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K911202Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992 · 2 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 19.4 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K983858.
How does its category compare?
All MIA devicesMIA Needle, Spinal, Short Term: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MIA
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MIA
Too few MIA 510(k)s in any year since 2007 to give a median.
Recalls per year · MIA
No recall names MIA since 2007.
Adverse event reports per year · MIA
14in 2025
MAUDE reports naming product code MIA, 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 | 5 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 23 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Portex® Lancet Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
The Portex® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172800: Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172800
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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