# K983858: Spinal Anesthesia Needles and Introducer Needles

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Inc.
- Decided: Jan 29, 1999 after 88 days
- Product code: MIA (Needle, Spinal, Short Term)
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K885277 (1989). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911221: Atraumatic Special Sprotte Needle, Pajunk GmbH (1992) Summary page 2.
- K911202: Atraumatic Standard Sprotte Needle, Pajunk GmbH (1992) Summary page 2.
- K885277: Spinal Anesthesia Tray, Preferred Medical Products (1989) Summary page 2.
- (no number) Becton-Dickinson spinal needles: named in the summary without a submission number
- (no number) Sherwood Medical introducer needle: named in the summary without a submission number
- (no number) American Medical Instruments, Inc. introducer needles: named in the summary without a submission number

## Most influential descendants
- K172800: Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors (2018), 0 descendants of its own
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

## Indications for use
Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.

Source page: https://510kreport.com/device/K983858
Methodology: https://510kreport.com/methodology