Atlas FDA

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

Avid N.I.T., Inc. — Predicate Candidate Screening

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

166 daysmedian FDA review time
313 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K014246AVID-NIT NERVE STIMULATION NEEDLESAvid N.I.T., Inc.2002-07-162020
K013231AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVIAvid N.I.T., Inc.2001-12-03670
K983218N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLEAvid N.I.T., Inc.1998-11-06530
K972595ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCERAvid N.I.T., Inc.1998-05-203130
K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.1998-02-172240
K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.1998-01-271660
K973638N.I.T., INC. NEEDLE GUIDING TEMPLATEAvid N.I.T., Inc.1997-12-23900
K971645REGANES SPINAL NEEDLE (VARIOUS)Avid N.I.T., Inc.1997-08-01880
K945965ATRAUMATIC PENCIL POINT SPINAL NEEDLEAvid N.I.T., Inc.1995-08-022380

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