Atlas FDA

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

Stainless Mfg., Inc. — Predicate Candidate Screening

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

36 daysmedian FDA review time
36 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841980SIDE CUTTING SERRATED BLADEStainless Mfg., Inc.1984-08-15930
K841970CAMELBACK HANDLE-K841969-LABELINGStainless Mfg., Inc.1984-06-19360
K841975ROSETTE KNIFE 4MMStainless Mfg., Inc.1984-06-19360
K841978LATERAL RELEASE KNIFE 5MM & 7MMStainless Mfg., Inc.1984-06-19360
K8419794MM CUP CURRETTEStainless Mfg., Inc.1984-06-19360
K8419712.5MM & 4MM PROBE K841969-LABELINGStainless Mfg., Inc.1984-06-19360
K841982MENISCOTOME 4MM & 5MMStainless Mfg., Inc.1984-06-19360
K841976HOOK KNIFE 4MM & 5MMStainless Mfg., Inc.1984-06-19360
K8419696.5MM HEX HANDLEStainless Mfg., Inc.1984-06-19360
K8419814MM & 5MM FILEStainless Mfg., Inc.1984-06-19360
K841974RETROGRADE KNIFE 4MM & 5MMStainless Mfg., Inc.1984-06-19360
K841972BANANA KNIFE - K841969-LABELINGStainless Mfg., Inc.1984-06-19360
K8419775MM DOUGLE EDGE RING CURETTEStainless Mfg., Inc.1984-06-19360
K841973BANANA KNIFE SERRATEDStainless Mfg., Inc.1984-06-19360
K800729PROBEStainless Mfg., Inc.1980-04-0870
K800730RETROGRADE KNIFEStainless Mfg., Inc.1980-04-0870
K800733DOUBLE-EDGE CURETTEStainless Mfg., Inc.1980-04-0870
K800732MENISCOTOMEStainless Mfg., Inc.1980-04-0870
K800731MENISCAL SAWStainless Mfg., Inc.1980-04-0870

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