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

R.E. Brown Co., Inc. — Predicate Candidate Screening

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

79 daysmedian FDA review time
92 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K781624PACING LEAD MODEL BUS 860, BUS 890R.E. Brown Co., Inc.1978-12-21920
K781623PACING MODELS MUM 860, MUM 890R.E. Brown Co., Inc.1978-12-08790
K781622PACING LEAD ADAPTER MODEL ACS 16R.E. Brown Co., Inc.1978-12-08790
K781621PACING LEAD MODELS, MAM 1260 MAM 1290R.E. Brown Co., Inc.1978-12-08790
K781625PACING LEAD MODEL MVM 860, MVM 890R.E. Brown Co., Inc.1978-12-08790
K781626PACING LEAD ADAPTER, ACV 14, ACV 23R.E. Brown Co., Inc.1978-12-08790
K781619PACING LEAD MODELS SA, 350, SAM 500R.E. Brown Co., Inc.1978-12-08790
K781620PACING LEAD MODELS, MDM 1060, MDM 1090R.E. Brown Co., Inc.1978-12-08790
K781627PACING LEAD ADAPTER MODEL ADB 21R.E. Brown Co., Inc.1978-12-08790
K780781STILITH CARDIAC PACEMAKERS-M. 60 & 120R.E. Brown Co., Inc.1978-07-27760

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