Atlas FDA

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

International Medical Products, Inc. · Predicate Candidate Screening

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

98 daysmedian FDA review time
630 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981003ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXEInternational Medical Products, Inc.1998-06-16902
K973253ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETInternational Medical Products, Inc.1997-10-30620
K971053ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATInternational Medical Products, Inc.1997-06-16840
K920077NIKKISO NK PUMPInternational Medical Products, Inc.1993-09-296300
K923942RHOMBO MEDICAL RHOMBO-FILLInternational Medical Products, Inc.1993-03-242310
K900755DIGITAL CUFF PV GAUGEInternational Medical Products, Inc.1990-04-26690
K864984ROBINJECTInternational Medical Products, Inc.1987-06-291890
K863609SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22International Medical Products, Inc.1987-02-251620
K861539NIKKISO INFUSION PUMP MODEL PFA-02International Medical Products, Inc.1986-07-31980

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