Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Polymer Technology Systems, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
420 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, Ca | Polymer Technology Systems, Inc. | 2016-12-22 | 562 | 0 |
| K151530 | CardioChek Plus Test System | Polymer Technology Systems, Inc. | 2015-07-07 | 29 | 0 |
| K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM | Polymer Technology Systems, Inc. | 2015-05-22 | 494 | 0 |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Tes | Polymer Technology Systems, Inc. | 2014-10-02 | 45 | 0 |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2007-10-15 | 126 | 1 |
| K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2007-09-10 | 101 | 2 |
| K070017 | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2007-01-31 | 28 | 0 |
| K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS | Polymer Technology Systems, Inc. | 2006-04-05 | 28 | 0 |
| K041750 | PTS PANELS CHOL+GLU TEST PANEL | Polymer Technology Systems, Inc. | 2004-07-23 | 24 | 0 |
| K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS | Polymer Technology Systems, Inc. | 2004-07-06 | 111 | 1 |
| K023558 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2002-11-15 | 23 | 1 |
| K022898 | PTS PANELS LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2002-09-24 | 21 | 1 |
| K022401 | PTS PANELS MULTI-CHEMISTRY CONTROLS | Polymer Technology Systems, Inc. | 2002-08-21 | 29 | 0 |
| K014099 | BIOSCANNER PLUS | Polymer Technology Systems, Inc. | 2001-12-21 | 8 | 0 |
| K013068 | BIOSCANNER 2000 | Polymer Technology Systems, Inc. | 2001-11-20 | 145 | 1 |
| K013203 | BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS | Polymer Technology Systems, Inc. | 2001-11-16 | 52 | 0 |
| K013173 | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2001-10-22 | 28 | 0 |
| K010456 | BIOSCANNER CREATININE TEST STRIPS | Polymer Technology Systems, Inc. | 2001-06-20 | 124 | 1 |
| K000586 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | Polymer Technology Systems, Inc. | 2000-07-03 | 132 | 0 |
| K991894 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | Polymer Technology Systems, Inc. | 2000-05-24 | 356 | 0 |
| K993377 | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) | Polymer Technology Systems, Inc. | 2000-01-13 | 107 | 0 |
| K983860 | MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 | Polymer Technology Systems, Inc. | 1999-12-27 | 420 | 0 |
| K990688 | MTM BIOSCANNER C TEST STRIPS | Polymer Technology Systems, Inc. | 1999-06-24 | 119 | 1 |
| K990247 | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 | Polymer Technology Systems, Inc. | 1999-05-28 | 122 | 0 |
| K981865 | MTM BIOSCANNER K TEST STRIPS | Polymer Technology Systems, Inc. | 1999-02-26 | 274 | 0 |
| K981493 | MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, | Polymer Technology Systems, Inc. | 1998-07-22 | 86 | 1 |
| K972669 | MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER | Polymer Technology Systems, Inc. | 1998-01-22 | 190 | 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