Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quinton, Inc. — Predicate Candidate Screening
164 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
160 days90th percentile
164clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032038 | PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 | Quinton, Inc. | 2003-09-05 | 66 | 0 |
| K021906 | QUINTON Q-CATH, MODEL 000460 | Quinton, Inc. | 2002-09-04 | 86 | 0 |
| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 | Quinton, Inc. | 2001-01-25 | 66 | 1 |
| K001492 | QUINTON Q-STRESS, MODEL 000483 | Quinton, Inc. | 2000-08-09 | 89 | 0 |
| K992908 | Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) | Quinton, Inc. | 2000-03-06 | 189 | 0 |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Quinton, Inc. | 1999-04-29 | 44 | 1 |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | Quinton, Inc. | 1997-08-25 | 132 | 0 |
| K964784 | SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) | Quinton, Inc. | 1997-08-13 | 259 | 0 |
| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | Quinton, Inc. | 1997-05-21 | 160 | 0 |
| K955002 | MAHURKAR 8 FR DUAL LEMEN CATHETER | Quinton, Inc. | 1996-09-13 | 317 | 0 |
| K961014 | QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH | Quinton, Inc. | 1996-07-31 | 140 | 0 |
| K945626 | QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH | Quinton, Inc. | 1995-06-28 | 224 | 0 |
| K943349 | MAHURKAR DUAL LUMEN CATHETER | Quinton, Inc. | 1995-03-22 | 253 | 0 |
| K922254 | LUKENS 2-0 BRAIDED SILK SUTURES | Quinton, Inc. | 1992-09-01 | 203 | 0 |
| K910017 | Q4500 STREE TEST MONITOR | Quinton, Inc. | 1991-11-05 | 306 | 0 |
| K912227 | MONARK ERGOMETERS | Quinton, Inc. | 1991-08-07 | 83 | 0 |
| K910808 | Q-SMART HOLTER SYSTEMS | Quinton, Inc. | 1991-07-17 | 141 | 0 |
| K911751 | MEDTRACK TREADMILL | Quinton, Inc. | 1991-05-29 | 41 | 0 |
| K900835 | MODIFIED PERM-CATH | Quinton, Inc. | 1990-05-09 | 76 | 0 |
| K894650 | Q-PORT SYSTEM KIT | Quinton, Inc. | 1990-03-12 | 231 | 0 |
| K896252 | MODIFIED QUINTON SINGLE LUMEN CATHETER | Quinton, Inc. | 1990-01-29 | 91 | 0 |
| K895779 | MODIFIED PERMCATH TRAY (2ND SUBMISSION) | Quinton, Inc. | 1989-12-07 | 91 | 0 |
| K895440 | QUINTON MAHURKAR CATHETERS W/VITACUFF | Quinton, Inc. | 1989-11-29 | 85 | 0 |
| K892450 | MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS | Quinton, Inc. | 1989-10-11 | 184 | 0 |
| K893909 | MODIFIED MATERIAL USED IN INFUSION T | Quinton, Inc. | 1989-08-25 | 87 | 0 |
| K893420 | MASTERLAB PFT AND MASTERLAB BODY BOX | Quinton, Inc. | 1989-06-23 | 57 | 0 |
| K893188 | QUINTON SINGLE LUMEN CATHETER | Quinton, Inc. | 1989-06-08 | 34 | 0 |
| K892113 | Q5000 PC WORKSTATION | Quinton, Inc. | 1989-05-18 | 66 | 0 |
| K881235 | Q-PLEX 1 | Quinton, Inc. | 1989-03-31 | 374 | 0 |
| K890288 | PERITONEAL CATHETERS WITH AN ADDED FUNCTION | Quinton, Inc. | 1989-03-27 | 67 | 0 |
| K885000 | Q750 ELECTROCARDIOGRAPH | Quinton, Inc. | 1989-02-23 | 84 | 0 |
| K885188 | MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY | Quinton, Inc. | 1989-02-06 | 61 | 0 |
| K884102 | MODIFIED 7 INCH CONTINUOUS INFUSION SETS | Quinton, Inc. | 1989-01-31 | 144 | 0 |
| K883402 | EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER) | Quinton, Inc. | 1989-01-17 | 166 | 0 |
| K885062 | MODIFIED Q-SERIES OF TREADMILLS | Quinton, Inc. | 1988-12-27 | 21 | 0 |
| K883468 | Q5000 ST/HR SLOPE MODIFICATION | Quinton, Inc. | 1988-12-27 | 134 | 0 |
| K882978 | Q4000 OPTION FOR Q4000 | Quinton, Inc. | 1988-11-01 | 109 | 0 |
| K883009 | NON-CORING NEEDLES | Quinton, Inc. | 1988-10-04 | 77 | 0 |
| K883031 | Q-CATH RM | Quinton, Inc. | 1988-09-20 | 63 | 0 |
| K882097 | TUNNELING STYLET | Quinton, Inc. | 1988-07-28 | 70 | 0 |
| K881352 | RIGHT ATRIAL CATHETER INSERTION TRAY | Quinton, Inc. | 1988-06-09 | 71 | 0 |
| K880583 | MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH | Quinton, Inc. | 1988-02-22 | 13 | 0 |
| K874633 | PERMCATH INSERTION TRAY | Quinton, Inc. | 1988-02-17 | 100 | 0 |
| K880271 | RESUBMITTED EXCALIBUR | Quinton, Inc. | 1988-02-03 | 13 | 0 |
| K874632 | BENT NECK CURLCATH PERITONEAL DIALYSIS KIT | Quinton, Inc. | 1987-12-29 | 50 | 0 |
| K874403 | A SERIES OF 7 INCH CONTINUOUS INFUSION SETS | Quinton, Inc. | 1987-12-29 | 62 | 0 |
| K874650 | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) | Quinton, Inc. | 1987-12-09 | 26 | 0 |
| K873584 | MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR | Quinton, Inc. | 1987-10-26 | 52 | 0 |
| K873727 | PULL-APART INTRODUCER (SHEATH) | Quinton, Inc. | 1987-10-07 | 28 | 0 |
| K873394 | OVAL PULL-APART SHEATH/DILATOR | Quinton, Inc. | 1987-09-30 | 37 | 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