Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rexton, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
127 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970537 | REXTON MODEL 48 AND 49PP | Rexton, Inc. | 1997-03-28 | 44 | 0 |
| K964451 | PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO AT | Rexton, Inc. | 1996-11-27 | 21 | 0 |
| K960295 | LONG LIFE RX-12 | Rexton, Inc. | 1996-03-22 | 60 | 0 |
| K954922 | REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANN | Rexton, Inc. | 1996-01-17 | 83 | 0 |
| K953770 | REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY | Rexton, Inc. | 1995-09-18 | 35 | 0 |
| K950451 | M-29 PP-PC, M-29 PP-O/PC | Rexton, Inc. | 1995-03-21 | 46 | 0 |
| K944851 | MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC | Rexton, Inc. | 1995-02-22 | 145 | 0 |
| K944777 | ORION PPM, PP, PP-D | Rexton, Inc. | 1994-12-30 | 94 | 0 |
| K944359 | EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12 | Rexton, Inc. | 1994-12-29 | 113 | 0 |
| K942702 | DEEP CANAL HEARING INSTRUMENT | Rexton, Inc. | 1994-12-21 | 196 | 0 |
| K944548 | REXPLUS PP3 | Rexton, Inc. | 1994-11-14 | 59 | 0 |
| K915684 | REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION | Rexton, Inc. | 1992-01-09 | 21 | 0 |
| K915683 | REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION | Rexton, Inc. | 1992-01-09 | 21 | 0 |
| K901341 | REXTON RX12 POWER PLUS W/DUAL RECEIVER | Rexton, Inc. | 1990-07-27 | 127 | 0 |
| K900636 | REXTON PP 142, PP 142-L | Rexton, Inc. | 1990-03-27 | 46 | 0 |
| K896057 | MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID | Rexton, Inc. | 1990-01-16 | 90 | 0 |
| K896056 | REXTON RX12D CUSTOM IN-THE-EAR HEARING AID | Rexton, Inc. | 1990-01-10 | 84 | 0 |
| K892898 | ASTRO BEHIND-THE-EAR HEARING AID | Rexton, Inc. | 1989-08-08 | 110 | 0 |
| K892333 | REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID | Rexton, Inc. | 1989-05-19 | 44 | 0 |
| K861532 | RX-33S INTRA MINI CANAL MODULE | Rexton, Inc. | 1986-06-05 | 42 | 0 |
| K832180 | REXTON RX10, RX20-30 & 40 | Rexton, Inc. | 1983-09-29 | 85 | 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