Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Neocoil, LLC · Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

48 daysmedian FDA review time
160 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K2609470.55T 12Ch Breast CoilNeocoil, LLC2026-04-23310
K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil,Neocoil, LLC2022-10-14660
K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior Neocoil, LLC2022-03-111080
K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC2020-06-02390
K1829581.5T 16ch Breast CoilNeocoil, LLC2018-11-16230
K173409Wireless Audio SystemNeocoil, LLC2018-02-161070
K1733773.0T 16ch Breast CoilNeocoil, LLC2017-11-28290
K160350ECG CT Gating DeviceNeocoil, LLC2016-06-161290
K1418323T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGENeocoil, LLC2014-07-31240
K133670HEADPHONES, PATIENT ALERT, STANDALONE INTERFACENeocoil, LLC2014-07-242370
K1334221.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, Neocoil, LLC2013-12-26480
K1232721.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUMNeocoil, LLC2013-03-281600
K1213621.5T 16CH FLEX SPEEDER LARGENeocoil, LLC2012-06-15390
K1134741.5T GEM FLEX COILNeocoil, LLC2012-03-161150
K1033423.0T METAFLEXCOILNeocoil, LLC2010-12-23380
K101632METAFLEXCOILNeocoil, LLC2010-08-24750
K073181NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COILNeocoil, LLC2007-11-2180

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda