Atlas FDA

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

Midwest City Hearing Aid Center · Predicate Candidate Screening

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

32 daysmedian FDA review time
40 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970430ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCIMidwest City Hearing Aid Center1997-03-11350
K963604DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSIONMidwest City Hearing Aid Center1996-09-27180
K963607HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANALMidwest City Hearing Aid Center1996-09-20110
K953728RX12 LINEAR FULL SHELL AND IN THE CANALMidwest City Hearing Aid Center1995-09-12330
K953729K AMP FULL SHELL AND IN THE EARMidwest City Hearing Aid Center1995-09-12330
K953631SNIP INPUT COMPRESSION CLASS AMidwest City Hearing Aid Center1995-08-28420
K952986SPI-SECRET PERSONAL INSTRUMENT CICMidwest City Hearing Aid Center1995-08-07400
K952820MWCHAC 95 C 12345Midwest City Hearing Aid Center1995-07-21310
K952821MWCHAC 95 FS 12345Midwest City Hearing Aid Center1995-07-21310
K953036DB PUSH-PULL HEARING AIDMidwest City Hearing Aid Center1995-07-21320
K953038DYNAMIC EQ/CLASS DMidwest City Hearing Aid Center1995-07-21320
K953037CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT)Midwest City Hearing Aid Center1995-07-20310

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