Atlas FDA

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

Manan Manufacturing Co., Inc. · Predicate Candidate Screening

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

34 daysmedian FDA review time
76 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K873208MANAN TURNER STYLE NEEDLEManan Manufacturing Co., Inc.1987-08-25110
K864405MANAN CONTRAST MEDIA ADMINISTRATION SETManan Manufacturing Co., Inc.1986-12-18380
K863848MANAN BREST TUMOR LOCALIZATION NEEDLEManan Manufacturing Co., Inc.1986-10-14140
K851833MANAN SELDINGER NEEDLEManan Manufacturing Co., Inc.1985-07-11760
K852501MYELOGRAM PROCEDURE TRAYManan Manufacturing Co., Inc.1985-07-11290
K852018ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHRManan Manufacturing Co., Inc.1985-07-11640
K851832NAMAN POTTS COURNAND NEEDLEManan Manufacturing Co., Inc.1985-07-11760
K851834MANAN GWI GUIDE WIRE INTRODUCERManan Manufacturing Co., Inc.1985-07-11760
K852426MANAN TROCAR STYLE BIOPSY NEEDLEManan Manufacturing Co., Inc.1985-06-27200
K852428MANAN EPIDURAL NEEDLEManan Manufacturing Co., Inc.1985-06-27200
K852427MANAN SPINAL NEEDLEManan Manufacturing Co., Inc.1985-06-27200
K851836MANAN MENGHINI NEEDLEManan Manufacturing Co., Inc.1985-06-21540
K851839MANAN MADAYAG PTC NEEDLEManan Manufacturing Co., Inc.1985-06-21560
K851838MANAN CHIBA PTC NEEDLEManan Manufacturing Co., Inc.1985-06-21560
K852104MANAN PTC BIOPSY TRAYSManan Manufacturing Co., Inc.1985-06-19350
K852105MANAN UBK ULTRASONIC GUIDED BIOPSY KITManan Manufacturing Co., Inc.1985-06-18340
K851835MANAN GREENE NEEDLEManan Manufacturing Co., Inc.1985-05-17190
K851701MANAN ZAVALA NEEDLEManan Manufacturing Co., Inc.1985-05-14200
K851831MANAN FRANSEENE NEEDLEManan Manufacturing Co., Inc.1985-05-14180
K851837MANAN WESTCOTT NEEDLEManan Manufacturing Co., Inc.1985-05-14180

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