510(k) · Cleared

Recalled · Class II · 2016

3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, Large

K141832510(k) TraditionalCleared Jul 31, 201424-day reviewClass II21 CFR 892.1000Recalls 1

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

Neocoil, LLC · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jul 31, 2014 as substantially equivalent to K121362 (Neocoil, LLC, 2012) after a 24-day review. Its family tree reaches back 3 generations to 2010. It has been recalled once.

Decided: Jul 31, 2014
Review: 24 days
Class: Class II
Product code: MOS
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K101632 (2010). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK101632 MetaflexcoilNeocoil, LLC · 2010
2 generations backK113474 1.5T Gem Flex CoilNeocoil, LLC · 2012
1 generation backK121362 1.5T 16CH Flex Speeder LargeNeocoil, LLC · 2012
This deviceK141832 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, LargeNeocoil, LLC · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K101632	Metaflexcoil	Neocoil, LLC	2010	—
−2	K113474	1.5T Gem Flex Coil	Neocoil, LLC	2012	—
−1	K121362	1.5T 16CH Flex Speeder Large	Neocoil, LLC	2012	—
0 (this device)	K141832	3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, Large	Neocoil, LLC	2014	—

FIG. 1 — Lineage of K141832, 2010–2014Source: 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.

Planning a device in MOS? 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 MOS device

#1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K121362	1.5T 16CH Flex Speeder Large Summary page 3 …nd effective as the predicate device. As such, the 3T l6ch Flex SPEEDER Coils are equivalent to their predicate, 1.5T l6ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012. 0 2014 Neocoil, LLG Neocoil, LLC 3T l6ch Flex SPEEDER Coils - 510k S…	Neocoil, LLC	2012	—

Also cleared against K121362: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 17, 2016	Class II	Z-2312-2016	Nonconforming Material/Component	There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
None of the 3 ancestors has a recall.
3 other devices also cite its predicate K121362.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MOS

3in 2025

2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007high 178 (2019) · low 19 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOS

13in 2024

2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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	16	19	0	4
2008	19	33	2	2
2009	10	43	0	5
2010	16	78	1	13
2011	25	57	0	7
2012	15	49	1	12
2013	7	87	0	10
2014	12	60	0	4
2015	6	58	2	5
2016	11	42	0	7
2017	9	63	0	9
2018	10	30	0	7
2019	3	178	8	8
2020	5	51	1	2
2021	4	41	0	3
2022	11	79	0	5
2023	10	59	0	4
2024	10	39	13	8
2025	3	59	0	2
2026	10	45	0	—

What is it indicated for?

To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141832 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141832: 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141832

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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