Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exmoor Plastics , Ltd. — Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
310 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093863 | EPIDRUM | Exmoor Plastics , Ltd. | 2010-05-10 | 144 | 0 |
| K990366 | EXMOOR SUCTION CLEARANCE KIT | Exmoor Plastics , Ltd. | 1999-03-05 | 28 | 0 |
| K980828 | EXMOOR MYRINGOTOMY KIT | Exmoor Plastics , Ltd. | 1998-10-22 | 233 | 0 |
| K981143 | DILKES LASER/SUCTION CANNULAE | Exmoor Plastics , Ltd. | 1998-09-14 | 168 | 0 |
| K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT C | Exmoor Plastics , Ltd. | 1998-07-16 | 393 | 0 |
| K981088 | MILLS COLUMELLA PROSTHESIS | Exmoor Plastics , Ltd. | 1998-06-05 | 72 | 0 |
| K981045 | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS | Exmoor Plastics , Ltd. | 1998-05-20 | 61 | 0 |
| K974008 | PFLEIDERER'S INTRATYMPANIC CATHETER | Exmoor Plastics , Ltd. | 1998-05-13 | 208 | 0 |
| K974224 | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | Exmoor Plastics , Ltd. | 1998-01-27 | 78 | 0 |
| K973587 | EXMOOR TYMPANOCENTESIS KIT (TK/1) | Exmoor Plastics , Ltd. | 1998-01-23 | 123 | 0 |
| K974365 | MILLS INCUS HA SLEEVE | Exmoor Plastics , Ltd. | 1998-01-22 | 64 | 0 |
| K974007 | SHAH PERMAVENT | Exmoor Plastics , Ltd. | 1997-12-12 | 52 | 0 |
| K963899 | CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) | Exmoor Plastics , Ltd. | 1997-08-22 | 329 | 0 |
| K942745 | EXMOOR SINGLE USE MYRINGOTOMES | Exmoor Plastics , Ltd. | 1994-09-02 | 84 | 0 |
| K942746 | SUCKER ENDS (ZOELLNER) | Exmoor Plastics , Ltd. | 1994-08-24 | 75 | 0 |
| K926462 | BEL-AIR VENTILATION TUBE | Exmoor Plastics , Ltd. | 1993-05-05 | 132 | 0 |
| K921923 | TITANIUM VENTILATION TUBES | Exmoor Plastics , Ltd. | 1993-02-12 | 310 | 0 |
| K924901 | DEANS DISPOSABLE T-TUBE INSERTER | Exmoor Plastics , Ltd. | 1993-01-28 | 141 | 0 |
| K912486 | SINGH SPEECH SYSTEM (SERIES 'SSS') | Exmoor Plastics , Ltd. | 1992-09-04 | 458 | 0 |
| K911503 | EXMOOR SILICONE RUBBER SHEET | Exmoor Plastics , Ltd. | 1991-11-19 | 230 | 0 |
| K911580 | DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES | Exmoor Plastics , Ltd. | 1991-09-24 | 174 | 0 |
| K911613 | VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 | Exmoor Plastics , Ltd. | 1991-06-28 | 86 | 0 |
| K893006 | EXMOOR BITE BUFFER | Exmoor Plastics , Ltd. | 1990-03-05 | 315 | 0 |
| K892504 | 'EXMOOR' SINGLE USE SUCTION TUBE | Exmoor Plastics , Ltd. | 1989-06-22 | 72 | 0 |
| K883668 | SUNDERLAND NASAL TUBE | Exmoor Plastics , Ltd. | 1988-11-21 | 87 | 0 |
| K883667 | DONALDSON VENTILATION TUBES PT. # AG/S9 | Exmoor Plastics , Ltd. | 1988-11-14 | 80 | 0 |
| K864936 | 'EXMOOR' DAS GUPTA LARYNGEAL KEEL | Exmoor Plastics , Ltd. | 1987-04-27 | 132 | 0 |
| K864937 | 'EXMOOR' ZOELLNER SUCKER ENDS | Exmoor Plastics , Ltd. | 1987-03-30 | 104 | 0 |
| K871035 | 'EXMOOR' T-TUBE | Exmoor Plastics , Ltd. | 1987-03-23 | 6 | 0 |
| K864938 | 'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR | Exmoor Plastics , Ltd. | 1987-03-23 | 97 | 0 |
| K864930 | 'EXMOOR' ATKINS NASAL SPLINT | Exmoor Plastics , Ltd. | 1987-03-04 | 78 | 0 |
| K864933 | 'EXMOOR' SHAH & MACKAY NASAL SPLINTS | Exmoor Plastics , Ltd. | 1987-03-04 | 78 | 0 |
| K864932 | 'EXMOOR' CAWOOD NASAL SPLINTS | Exmoor Plastics , Ltd. | 1987-03-04 | 78 | 0 |
| K864934 | 'EXMOOR' SHAH SILICONE DISCS | Exmoor Plastics , Ltd. | 1987-01-28 | 43 | 0 |
| K864935 | 'EXMOOR' SHAH PACKING STRIPS | Exmoor Plastics , Ltd. | 1987-01-28 | 43 | 0 |
| K812459 | EXMOOR AURAL GROMMET AG/TI | Exmoor Plastics , Ltd. | 1981-09-25 | 25 | 0 |
| K812460 | VARIOUS AURAL GROMMETS | Exmoor Plastics , Ltd. | 1981-09-21 | 21 | 0 |
| K810705 | EXMOOR AURAL GROMMET AG/T4 | Exmoor Plastics , Ltd. | 1981-04-14 | 29 | 0 |
| K810701 | EXMOOR AURAL GROMMET | Exmoor Plastics , Ltd. | 1981-04-14 | 29 | 0 |
| K810704 | EXMOOR AURAL GROMMET AG/T3 | Exmoor Plastics , Ltd. | 1981-04-14 | 29 | 0 |
| K810702 | EXMOOR AURAL GROMMET AG/T2L | Exmoor Plastics , Ltd. | 1981-04-14 | 29 | 0 |
| K810706 | EXMOOR AURAL GROMMET AG/T5 | Exmoor Plastics , Ltd. | 1981-04-14 | 29 | 0 |
| K810703 | EXMOOR AURAL GROMMET AG/T2 | Exmoor Plastics , Ltd. | 1981-04-14 | 29 | 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