510(k) · Cleared

Cleared

Spinal Anesthesia Needles and Introducer Needles

K983858510(k) TraditionalCleared Jan 29, 199988-day reviewClass II21 CFR 868.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sims Portex, Inc. · MIA Needle, Spinal, Short Term

Cleared on Jan 29, 1999 as substantially equivalent to K911221 (Pajunk GmbH, 1992) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1989. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Jan 29, 1999
Review: 88 days
Class: Class II
Product code: MIA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K885277 (1989). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK885277 Spinal Anesthesia TrayPreferred Medical Products · 1989
This deviceK983858 Spinal Anesthesia Needles and Introducer NeedlesSims Portex, Inc. · 1999
Descendant · cites it directly · 0 of its ownK172800 Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex®…Smiths Medical Asd, Inc. · 2018
Descendant · cites it directly · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005

Class I recalls in this family

K911202 Atraumatic Standard Sprotte Needledirect predicate · 1992

Most influential descendants

Showing 2 of 2 · See all

K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal…Smiths Medical Asd, Inc. · 2018 · cites it directly0descendants
K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K885277	Spinal Anesthesia Tray	Preferred Medical Products	1989	—
0 (this device)	K983858	Spinal Anesthesia Needles and Introducer Needles	Sims Portex, Inc.	1999	—
+1	K172800	Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil…	Smiths Medical Asd, Inc.	2018	—
+1	K052435	Pneumrx Family of Biopsy Needles and Kits	Pneumrx, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	2	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2018	1	0

FIG. 1 — Lineage of K983858, 1989–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K911221	Atraumatic Special Sprotte Needle Summary page 2 …EDICATE DEVICE(S): Becton-Dickinson spinal needles, marketed as preamendment devices. Pajunk Medizintechnologie, Germany, Sprotte spinal needles, marketed under 510(k) K911221 and K911202. Preferred Medical Products ( a division of Ballard Medical Products), spinal needles purchased from Unisis Corp., T…	Pajunk GmbH	1992	—
*	K911202	Atraumatic Standard Sprotte Needle Summary page 2 …CE(S): Becton-Dickinson spinal needles, marketed as preamendment devices. Pajunk Medizintechnologie, Germany, Sprotte spinal needles, marketed under 510(k) K911221 and K911202. Preferred Medical Products ( a division of Ballard Medical Products), spinal needles purchased from Unisis Corp., Tokyo, Japan,…	Pajunk GmbH	1992	Class I
*	K885277	Spinal Anesthesia Tray Summary page 2 …0(k) K911221 and K911202. Preferred Medical Products ( a division of Ballard Medical Products), spinal needles purchased from Unisis Corp., Tokyo, Japan, marketed under K885277. Sherwood Medical, introducer needle, marketed as preamendment device. American Medical Instruments, Inc., New Bedford, MA, int…	Preferred Medical Products	1989	—
*	—	Becton-Dickinson spinal needles Named without a submission number			—
*	—	Sherwood Medical introducer needle Named without a submission number			—
*	—	American Medical Instruments, Inc. introducer needles Named without a submission number			—

Also cleared against K911221: 4 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K172800	Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal…	Smiths Medical Asd, Inc.	2018	0
K052435	Pneumrx Family of Biopsy Needles and Kits	Pneumrx, Inc.	2005	0

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 · Direct predicate · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K172800 (Smiths Medical Asd, Inc., 2018) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K911221.

How does its category compare?

All MIA devices

MIA Needle, Spinal, Short Term: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MIA

1in 2018

2007high 1 (2018) · low 0 (2007)2026

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

2007high 23 (2016) · low 0 (2011)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	MAUDE reports
2007	0	—	5
2008	0	—	6
2009	0	—	4
2010	0	—	1
2011	0	—	0
2012	0	—	3
2013	0	—	2
2014	0	—	4
2015	0	—	12
2016	0	—	23
2017	0	—	15
2018	1	—	14
2019	0	—	9
2020	0	—	5
2021	0	—	4
2022	0	—	19
2023	0	—	12
2024	0	—	23
2025	0	—	14
2026	0	—	—

What is it indicated for?

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

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/K983858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983858: Spinal Anesthesia Needles and Introducer Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983858

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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