Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maico Hearing Instruments, Inc. · Predicate Candidate Screening
58 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
147 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960031 | AUDIOFLEX 120 | Maico Hearing Instruments, Inc. | 1996-03-07 | 65 | 0 |
| K954054 | MAICO PRODIGY CIC SERIES | Maico Hearing Instruments, Inc. | 1995-09-28 | 30 | 0 |
| K953161 | MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACH | Maico Hearing Instruments, Inc. | 1995-07-24 | 17 | 0 |
| K950637 | MAICO IN-THE-EAR MODEL RD-312 CIC | Maico Hearing Instruments, Inc. | 1995-03-21 | 36 | 0 |
| K946253 | MAICO IN-THE-EAR MODEL RD 201 | Maico Hearing Instruments, Inc. | 1995-01-30 | 38 | 0 |
| K931322 | KS 5 - CLINICAL AUDIOMETER | Maico Hearing Instruments, Inc. | 1994-08-19 | 521 | 0 |
| K933291 | MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID | Maico Hearing Instruments, Inc. | 1993-08-23 | 48 | 0 |
| K926439 | MA25 - PORTABLE AUDIOMETER, MODIFICATION | Maico Hearing Instruments, Inc. | 1993-08-05 | 225 | 0 |
| K930112 | MAICO MA790 AUDIOMETER | Maico Hearing Instruments, Inc. | 1993-08-05 | 206 | 0 |
| K931160 | SERIES STAR 66 BEKHIND THE EAR HEARING AID | Maico Hearing Instruments, Inc. | 1993-06-01 | 85 | 0 |
| K931161 | SERIES STAR 22 - BEHIND THE EAR HEARING AID | Maico Hearing Instruments, Inc. | 1993-06-01 | 85 | 0 |
| K931040 | MT 80 SP | Maico Hearing Instruments, Inc. | 1993-06-01 | 92 | 0 |
| K931041 | STAR 42 PP-SP, STAR 42 PP-SL (T100) | Maico Hearing Instruments, Inc. | 1993-06-01 | 92 | 0 |
| K931035 | MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID | Maico Hearing Instruments, Inc. | 1993-06-01 | 92 | 0 |
| K922746 | ST 20 PORTABLE AUDIOMETER | Maico Hearing Instruments, Inc. | 1992-11-05 | 150 | 0 |
| K911368 | MAICO MA800 AUDIOMETER | Maico Hearing Instruments, Inc. | 1991-06-26 | 90 | 0 |
| K905704 | MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER | Maico Hearing Instruments, Inc. | 1991-04-30 | 130 | 0 |
| K903583 | SERIES MCAXX (MODEL 851) ITE HEARING AID | Maico Hearing Instruments, Inc. | 1990-10-09 | 62 | 0 |
| K895310 | AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7 | Maico Hearing Instruments, Inc. | 1990-01-23 | 147 | 0 |
| K890993 | AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID | Maico Hearing Instruments, Inc. | 1989-10-12 | 227 | 0 |
| K890842 | 2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY | Maico Hearing Instruments, Inc. | 1989-06-07 | 106 | 0 |
| K882691 | MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX | Maico Hearing Instruments, Inc. | 1988-08-30 | 63 | 0 |
| K882692 | MODEL P20/P21 IN-THE-EAR HEARING AID | Maico Hearing Instruments, Inc. | 1988-07-15 | 17 | 0 |
| K880466 | SERIES S415/S425 - BEHIND-THE-EAR HEARING AID | Maico Hearing Instruments, Inc. | 1988-02-23 | 20 | 0 |
| K880465 | SERIES S515/S525 BEHIND-THE-EAR HEARING AID | Maico Hearing Instruments, Inc. | 1988-02-23 | 20 | 0 |
| K873468 | CUSTOM IN-THE-EAR HEARING AID SERIES MCA20 | Maico Hearing Instruments, Inc. | 1987-09-29 | 32 | 0 |
| K862770 | AUDIOMETER/MASTER HEARING AID MF6 | Maico Hearing Instruments, Inc. | 1986-08-15 | 24 | 0 |
| K862769 | FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR | Maico Hearing Instruments, Inc. | 1986-08-13 | 22 | 0 |
| K862768 | FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 | Maico Hearing Instruments, Inc. | 1986-08-13 | 22 | 0 |
| K861597 | BEHING-THE-EAR HEARING AID SERIES SP | Maico Hearing Instruments, Inc. | 1986-06-02 | 34 | 0 |
| K853919 | MA25 PORTABLE AUDIOMETER | Maico Hearing Instruments, Inc. | 1985-12-18 | 86 | 0 |
| K841568 | IMPEDANCE/PURE TONE AUDIOMETER MA620 | Maico Hearing Instruments, Inc. | 1984-07-18 | 92 | 0 |
| K841567 | AUDIOMETER MA728 | Maico Hearing Instruments, Inc. | 1984-06-27 | 71 | 0 |
| K840298 | MCA IN THE EAR CUSTOM HEARING AID | Maico Hearing Instruments, Inc. | 1984-04-17 | 84 | 0 |
| K840825 | SERIES MR IN-THE-EAR CUSTOM HEARING AID | Maico Hearing Instruments, Inc. | 1984-03-30 | 35 | 0 |
| K831754 | MA 610-IMPEDANCE AUDIOMETER | Maico Hearing Instruments, Inc. | 1983-07-07 | 36 | 0 |
| K831755 | MA600-IMPEDANCE AUDIOMETER | Maico Hearing Instruments, Inc. | 1983-07-06 | 35 | 0 |
| K821760 | SERIES M PUSH-PULL INPUT COMPRESSION | Maico Hearing Instruments, Inc. | 1982-06-25 | 10 | 0 |
| K811727 | PORTABLE AUDIOMETERS | Maico Hearing Instruments, Inc. | 1981-07-15 | 27 | 0 |
| K811344 | BEHIND-THE-EAR HEARING AID | Maico Hearing Instruments, Inc. | 1981-06-16 | 35 | 0 |
| K801062 | BEHIND-THE-EAR HEARING AID SERIES G | Maico Hearing Instruments, Inc. | 1980-06-04 | 29 | 0 |
| K792198 | SERIES S (BEHIND-THE-EAR-HEARING AID) | Maico Hearing Instruments, Inc. | 1979-11-27 | 26 | 0 |
| K791170 | MIS AURAL ACOUSTIC SCREENER | Maico Hearing Instruments, Inc. | 1979-06-25 | 0 | 0 |
| K780382 | AUDIOMETER, PORTABLE, AIR CONDUCTION | Maico Hearing Instruments, Inc. | 1978-03-14 | 4 | 0 |
| K780270 | COMPUTER AUDIOMETER - MA26 | Maico Hearing Instruments, Inc. | 1978-02-27 | 6 | 0 |
| K780269 | COMPUTER AUDIOMETER - MA25 | Maico Hearing Instruments, Inc. | 1978-02-27 | 6 | 0 |
| K780067 | HEARING AID, BEHIND-THE-EAR | Maico Hearing Instruments, Inc. | 1978-01-20 | 8 | 0 |
| K772201 | HEARING AID, BODY TYPE, MODEL H | Maico Hearing Instruments, Inc. | 1977-12-20 | 20 | 0 |
| K770960 | HEARING AID, SERIES R | Maico Hearing Instruments, Inc. | 1977-06-14 | 18 | 0 |
| K770885 | HEARING AID, SERIES K-BEHIND-THE-EAR | Maico Hearing Instruments, Inc. | 1977-05-25 | 9 | 0 |
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