Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unitron Industries, Inc. — Predicate Candidate Screening
69 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
89 days90th percentile
69clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Unitron Industries, Inc. | 1997-12-12 | 24 | 0 |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Unitron Industries, Inc. | 1997-12-12 | 24 | 0 |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Unitron Industries, Inc. | 1997-12-12 | 24 | 0 |
| K970692 | UNITRON MODEL SOUND F/X CIC | Unitron Industries, Inc. | 1997-05-08 | 72 | 0 |
| K970519 | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) | Unitron Industries, Inc. | 1997-04-24 | 72 | 0 |
| K964508 | UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) | Unitron Industries, Inc. | 1996-11-27 | 19 | 0 |
| K964510 | UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) | Unitron Industries, Inc. | 1996-11-27 | 19 | 0 |
| K964503 | UNITRON MODEL SOUND F/X +4 | Unitron Industries, Inc. | 1996-11-27 | 19 | 0 |
| K964511 | UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) | Unitron Industries, Inc. | 1996-11-27 | 19 | 0 |
| K964502 | UNITRON MODEL SOUND F/XP +4 | Unitron Industries, Inc. | 1996-11-27 | 19 | 0 |
| K964504 | UNITRON MODEL ICON AOHPL +4 | Unitron Industries, Inc. | 1996-11-27 | 19 | 0 |
| K963122 | UNITRON MODEL ICON KR | Unitron Industries, Inc. | 1996-09-06 | 25 | 0 |
| K960155 | UNITRON MODEL SOUND F/XP | Unitron Industries, Inc. | 1996-03-07 | 56 | 0 |
| K954516 | UNITRON MODEL SOUND F/X II | Unitron Industries, Inc. | 1995-10-07 | 9 | 0 |
| K953727 | UNITRON MODEL IKON AOHPD | Unitron Industries, Inc. | 1995-10-07 | 58 | 0 |
| K953932 | UNITRON MODEL SOUND F/XD | Unitron Industries, Inc. | 1995-10-07 | 61 | 0 |
| K954430 | UNITRON MODEL SOUND F/X | Unitron Industries, Inc. | 1995-10-06 | 14 | 0 |
| K953646 | UNITRON MODEL IKON AOHPL | Unitron Industries, Inc. | 1995-08-28 | 24 | 0 |
| K950759 | UNITRON MODEL ESTEEM | Unitron Industries, Inc. | 1995-03-31 | 42 | 0 |
| K946323 | UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID | Unitron Industries, Inc. | 1995-01-30 | 32 | 0 |
| K946264 | UNITRON MODEL SOUNG F/S | Unitron Industries, Inc. | 1995-01-26 | 34 | 0 |
| K944520 | AIR CONDUCTION HEARING AID | Unitron Industries, Inc. | 1994-12-27 | 102 | 0 |
| K935867 | AIR CONDUCTION HEARING AID, UNITRON IKON K & KD | Unitron Industries, Inc. | 1994-03-22 | 106 | 0 |
| K936106 | AIR CONDUCTION HEARING AID: IKON PP | Unitron Industries, Inc. | 1994-03-21 | 89 | 0 |
| K934565 | UNITRON MODEL IKON AGCO/ AOD | Unitron Industries, Inc. | 1993-11-29 | 74 | 0 |
| K934586 | PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID | Unitron Industries, Inc. | 1993-11-19 | 57 | 0 |
| K925600 | VISTA 4000 SIGMA | Unitron Industries, Inc. | 1993-02-08 | 95 | 0 |
| K914689 | HEARING AID, UNITRON MODEL VISTA 4000 | Unitron Industries, Inc. | 1991-11-05 | 18 | 0 |
| K914688 | HEARING AID, UNITRON MODEL VISTA 3000 | Unitron Industries, Inc. | 1991-11-05 | 18 | 0 |
| K912870 | HEARING AID, UNITRON MODEL UIK | Unitron Industries, Inc. | 1991-07-31 | 33 | 0 |
| K904576 | HEARING AID, UNITRON MODEL UM60-UH | Unitron Industries, Inc. | 1990-12-07 | 59 | 0 |
| K901569 | BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL | Unitron Industries, Inc. | 1990-04-18 | 14 | 0 |
| K884288 | HEARING AID, UNITRON BTE MODEL UM60-AGC0 | Unitron Industries, Inc. | 1989-01-03 | 83 | 0 |
| K883513 | HEARING AID, UNITRON MODEL VISTA 1000 | Unitron Industries, Inc. | 1988-09-01 | 15 | 0 |
| K882375 | HEARING AID, UNITRON MODEL UI5 | Unitron Industries, Inc. | 1988-08-09 | 62 | 0 |
| K870503 | HEARING AID, UNITRON MODEL UM60 | Unitron Industries, Inc. | 1987-03-11 | 35 | 0 |
| K863225 | UNITRON MODEL UL21 HEARING AID | Unitron Industries, Inc. | 1986-10-24 | 64 | 0 |
| K862760 | HEARING AID, UNITRON MODEL UF11 | Unitron Industries, Inc. | 1986-07-31 | 9 | 0 |
| K853781 | UNITRON MODEL UM60-PP | Unitron Industries, Inc. | 1985-11-07 | 59 | 0 |
| K853780 | UNITRON MODEL UM60-D | Unitron Industries, Inc. | 1985-11-07 | 59 | 0 |
| K852690 | HEARING AID, UNITRON MODEL UM60-H | Unitron Industries, Inc. | 1985-07-31 | 36 | 0 |
| K850914 | HEARING AID, UNITRON MODEL UC | Unitron Industries, Inc. | 1985-06-05 | 92 | 0 |
| K843246 | HEARING AID, UNITRON UE12-PPL | Unitron Industries, Inc. | 1985-01-23 | 156 | 0 |
| K843245 | HEARING AID, UNITRON UE12-PP | Unitron Industries, Inc. | 1985-01-10 | 143 | 0 |
| K840842 | HEARING AID UNITRON UE8 | Unitron Industries, Inc. | 1984-03-30 | 35 | 0 |
| K833614 | HEARING AID, UNITRON UT1 | Unitron Industries, Inc. | 1983-11-21 | 39 | 0 |
| K833615 | HEARING AID UNITRON UI3 | Unitron Industries, Inc. | 1983-11-21 | 39 | 0 |
| K831883 | HEARING AID UNITRON #UE8-D | Unitron Industries, Inc. | 1983-08-12 | 60 | 0 |
| K830402 | HEARING AID, #UE7-D | Unitron Industries, Inc. | 1983-03-07 | 28 | 0 |
| K823669 | HEARING AID UNITRON #UE4-H | Unitron Industries, Inc. | 1982-12-28 | 21 | 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