Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Norton Performance Plastics Corp. — Predicate Candidate Screening
39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
88 days90th percentile
39clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853791 | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 | Norton Performance Plastics Corp. | 1985-12-09 | 89 | 0 |
| K852914 | ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION | Norton Performance Plastics Corp. | 1985-09-25 | 77 | 0 |
| K851299 | CORRECT FLO | Norton Performance Plastics Corp. | 1985-05-07 | 36 | 0 |
| K842858 | FLUID ADMINISTRATION LINE W/SPIKE 14-923 | Norton Performance Plastics Corp. | 1984-09-11 | 50 | 0 |
| K841828 | CENTRAL VENOUS CATHETER W/BIG-GARD | Norton Performance Plastics Corp. | 1984-07-13 | 71 | 0 |
| K840240 | MICROFUSE INTRAVENOUS CATHETER SET | Norton Performance Plastics Corp. | 1984-04-17 | 88 | 0 |
| K831587 | TEMP. REPAIR KIT-DUAL LUMEN CATHETER | Norton Performance Plastics Corp. | 1983-10-19 | 155 | 0 |
| K831698 | DISPOSABLE PRESSURE TRANSDUCER#14004195 | Norton Performance Plastics Corp. | 1983-08-11 | 78 | 0 |
| K830788 | CENTRAL VEIN CATHERIZATION KIT-14-690- | Norton Performance Plastics Corp. | 1983-04-30 | 47 | 0 |
| K830813 | FRENCH PERCUTANEOUS SHEATH INTRODUCER | Norton Performance Plastics Corp. | 1983-04-28 | 45 | 0 |
| K830969 | PERM. REPAIR KIT FOR LEONARD NORTON DUAL | Norton Performance Plastics Corp. | 1983-04-14 | 17 | 0 |
| K821996 | LEONARD PERIPHERAL VENOUS PRESSURE CATH | Norton Performance Plastics Corp. | 1982-07-30 | 23 | 0 |
| K821679 | LEONARD/NORTON HYPERALIMENTATION CATHET. | Norton Performance Plastics Corp. | 1982-07-02 | 24 | 0 |
| K820864 | NORTON MANIFOLD | Norton Performance Plastics Corp. | 1982-04-15 | 17 | 0 |
| K820710 | NEONATAL INTRODUCER KIT | Norton Performance Plastics Corp. | 1982-04-01 | 14 | 0 |
| K820677 | TOUCH FLUSH CONTINUOUS FAST/FLUSH | Norton Performance Plastics Corp. | 1982-03-25 | 14 | 0 |
| K820676 | TOUCH FLUSH W/Y TRANSDUCER CONNECTOR | Norton Performance Plastics Corp. | 1982-03-25 | 14 | 0 |
| K820581 | NORTON JUGULAR KITS | Norton Performance Plastics Corp. | 1982-03-18 | 14 | 0 |
| K820229 | NORTON FLOW DIRECTED THERMODILUTION CATH | Norton Performance Plastics Corp. | 1982-02-12 | 16 | 0 |
| K813137 | CORREC TORR TM | Norton Performance Plastics Corp. | 1981-12-02 | 27 | 0 |
| K802945 | PRESSURE MONITORING SET | Norton Performance Plastics Corp. | 1980-12-19 | 30 | 0 |
| K800622 | EXTENSION LINE | Norton Performance Plastics Corp. | 1980-04-29 | 42 | 0 |
| K800620 | VENOUS M/A INTERNAL JUGULAR KIT | Norton Performance Plastics Corp. | 1980-04-24 | 37 | 0 |
| K800618 | SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET | Norton Performance Plastics Corp. | 1980-04-24 | 37 | 0 |
| K800619 | THERMODILUTION CATHETER INTRO. KIT | Norton Performance Plastics Corp. | 1980-04-24 | 37 | 0 |
| K800621 | PERCUTANEOUS CATHETER INTRODUCER ADAPTER | Norton Performance Plastics Corp. | 1980-04-24 | 37 | 0 |
| K791512 | CONTINUOUS AMBULATORY DIALYSIS (CAPD) | Norton Performance Plastics Corp. | 1980-02-06 | 201 | 0 |
| K791890 | CONTINUOUS FLUSH DEVICE, CAT. #14-370 | Norton Performance Plastics Corp. | 1979-12-13 | 79 | 0 |
| K791107 | STOPCOCK, THREE WAY | Norton Performance Plastics Corp. | 1979-06-22 | 8 | 0 |
| K790604 | CUSTOM TUBING SETS | Norton Performance Plastics Corp. | 1979-05-04 | 46 | 0 |
| K790358 | FLUID ADMINISTRATION CAT.#14-923 | Norton Performance Plastics Corp. | 1979-03-21 | 36 | 0 |
| K780985 | PVC LINES FOR MONITORING | Norton Performance Plastics Corp. | 1978-07-27 | 43 | 0 |
| K780984 | PVC QUICK PRIME LINES | Norton Performance Plastics Corp. | 1978-07-17 | 33 | 0 |
| K780662 | SUPPLEMENTAL TYGON PAC-MONITORING LINES | Norton Performance Plastics Corp. | 1978-06-06 | 49 | 0 |
| K771387 | MONITORING LINES & FLUID ADMIN. | Norton Performance Plastics Corp. | 1977-08-22 | 26 | 0 |
| K770916 | TYGON PAC-MONITORING LINES & FLUID ADMIN | Norton Performance Plastics Corp. | 1977-06-17 | 29 | 0 |
| K770708 | TYGON PAC-STOPCOCKS | Norton Performance Plastics Corp. | 1977-06-08 | 51 | 0 |
| K770707 | TYGON PAC-MONITORING LINES & FLUID ADMIN | Norton Performance Plastics Corp. | 1977-06-03 | 46 | 0 |
| K770299 | TYGON M-60/TYGON M-70 | Norton Performance Plastics Corp. | 1977-03-16 | 30 | 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