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

Solway, Inc. — Predicate Candidate Screening

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

28 daysmedian FDA review time
62 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K874960CARDIOVASCULAR SURGICAL INSTRUMENTSSolway, Inc.1988-02-05650
K874962FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULASSolway, Inc.1988-02-02620
K874956SELF-RETAINING RETRACTOR FOR NEUROSURGERYSolway, Inc.1988-01-28570
K874964DENTAL HAND INSTRUMENTSSolway, Inc.1988-01-27560
K875043RONGEUR (NEUROSURGICAL INSTRUMENTS)Solway, Inc.1988-01-22510
K874966TUNING FORKSSolway, Inc.1988-01-04330
K874954MANUAL RONGEURSolway, Inc.1987-12-30280
K874952MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIESSolway, Inc.1987-12-30280
K874961BONE CUTTING INSTRUMENTS & ACCESSORIESSolway, Inc.1987-12-30280
K874959VASCULAR CLAMPSolway, Inc.1987-12-30280
K874950MICROSURGICAL INSTRUMENTSSolway, Inc.1987-12-30280
K874965MANUAL SURGICAL INSTRUMENTS FOR GENERAL USESolway, Inc.1987-12-30280
K874963MANUAL OPHTHALMIC SURGICAL INSTRUMENTSSolway, Inc.1987-12-23210

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