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

Miracle-Ear/Dahlberg, Inc. · Predicate Candidate Screening

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

58 daysmedian FDA review time
91 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942895MIRACLE EAR MODEL PGMMiracle-Ear/Dahlberg, Inc.1994-08-17580
K942893MIRACLE-EAR MODEL PGF + REMOTEMiracle-Ear/Dahlberg, Inc.1994-08-17580
K942894MIRACLE-EAR MODEL PGCMiracle-Ear/Dahlberg, Inc.1994-08-17580
K941859MIRACLE-EAR EAR IMPRESSION MATERIALMiracle-Ear/Dahlberg, Inc.1994-07-251010
K862104MODEL UC SPECTRUM IN-THE-CANAL HEARING AIDMiracle-Ear/Dahlberg, Inc.1986-06-23210
K862103MODEL UC IN-THE-CANAL HEARING AIDMiracle-Ear/Dahlberg, Inc.1986-06-23210
K862099DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1986-06-23210
K862102MODEL KM IN-THE-CANAL HEARING AIDMiracle-Ear/Dahlberg, Inc.1986-06-23210
K862101MODEL UM IN-THE-CANAL HEARING AIDMiracle-Ear/Dahlberg, Inc.1986-06-23210
K862100MODEL ED BEHIND-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1986-06-23210
K860671DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1986-04-03380
K854835DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETERMiracle-Ear/Dahlberg, Inc.1986-03-04910
K854834DAHLBERG MODEL KC IN-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1986-03-04910
K853323DAHLBERG EA BEHING-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-09-23460
K853324DAHLBERG EB BEHING-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-09-23460
K853325DAHLBERG EC BEHIND-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-09-23460
K852486DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-08-22720
K852098DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-08-16930
K851869DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-07-05670
K851866DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-07-05670
K851810MODEL DA BEHIND-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-07-05700
K851867DAHLBERG MODEL DD BEHING-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-07-05670
K851868DAHLBERT MODEL DE BEHING-THE-EAR HEARING AIDMiracle-Ear/Dahlberg, Inc.1985-07-01630

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