Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Primrose Medical, Inc. · Predicate Candidate Screening

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

85 daysmedian FDA review time
325 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K884711URETHRAL AND URETERAL BALLOON DILATATORSPrimrose Medical, Inc.1989-09-293250
K884713COLONIC BALLOON DIALATORSPrimrose Medical, Inc.1989-09-293250
K884714BILIARY DIALATORPrimrose Medical, Inc.1989-09-293250
K884715ACHELASIA BALLOON DIALATORPrimrose Medical, Inc.1989-09-293250
K884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)Primrose Medical, Inc.1989-09-083040
K884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSPrimrose Medical, Inc.1989-09-083040
K883420LANCET, BLOODPrimrose Medical, Inc.1988-08-26110
K881976CATHETER, INTRAVASCULARPrimrose Medical, Inc.1988-08-04850
K881975SET, INTRAVASCULARPrimrose Medical, Inc.1988-07-29790
K881977PRESSURE INFUSORPrimrose Medical, Inc.1988-07-29790
K881978ENTERAL FEEDING TUBESPrimrose Medical, Inc.1988-07-13630
K873493NINJA SCALPELPrimrose Medical, Inc.1987-09-24240
K843070ESOPHAGEAL STETHOSCOPESPrimrose Medical, Inc.1984-08-24180
K843071ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTORPrimrose Medical, Inc.1984-08-24180

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