Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Telectronics Pacing Systems, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
314 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961118 | MAXIM PF MODELS 033-581/033-590 | Telectronics Pacing Systems, Inc. | 1996-07-15 | 117 | 0 |
| K943657 | STERILIZATION | Telectronics Pacing Systems, Inc. | 1996-06-24 | 698 | 0 |
| K934899 | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | Telectronics Pacing Systems, Inc. | 1994-05-12 | 210 | 0 |
| K926340 | NEW LEAD INTRODUCER KITS, VARIOUS MODELS | Telectronics Pacing Systems, Inc. | 1993-05-27 | 161 | 0 |
| K914489 | NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING | Telectronics Pacing Systems, Inc. | 1992-08-17 | 314 | 0 |
| K913919 | UNIVERSAL TERMINAL CAP, 3.2MM | Telectronics Pacing Systems, Inc. | 1991-12-31 | 119 | 0 |
| K912773 | UNIPOLAR UPSIZING ADAPTOR | Telectronics Pacing Systems, Inc. | 1991-10-23 | 121 | 0 |
| K911273 | 100 CM PERMANENT PACING LEAD MODELS | Telectronics Pacing Systems, Inc. | 1991-08-28 | 159 | 0 |
| K910112 | BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR | Telectronics Pacing Systems, Inc. | 1991-02-25 | 46 | 0 |
| K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | Telectronics Pacing Systems, Inc. | 1991-01-18 | 183 | 0 |
| K904741 | LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES | Telectronics Pacing Systems, Inc. | 1991-01-08 | 82 | 0 |
| K903221 | LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN | Telectronics Pacing Systems, Inc. | 1990-11-08 | 108 | 0 |
| K900645 | LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING | Telectronics Pacing Systems, Inc. | 1990-08-08 | 180 | 0 |
| K901402 | VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 | Telectronics Pacing Systems, Inc. | 1990-06-12 | 78 | 0 |
| K896438 | UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER | Telectronics Pacing Systems, Inc. | 1990-04-10 | 152 | 0 |
| K897116 | OPTIMA MPT MODEL 5281E AND MODEL 5282E | Telectronics Pacing Systems, Inc. | 1990-03-14 | 78 | 0 |
| K895971 | TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING | Telectronics Pacing Systems, Inc. | 1990-02-22 | 132 | 0 |
| K897067 | MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES | Telectronics Pacing Systems, Inc. | 1990-02-05 | 46 | 0 |
| K893041 | NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI | Telectronics Pacing Systems, Inc. | 1989-11-14 | 204 | 0 |
| K894185 | OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR | Telectronics Pacing Systems, Inc. | 1989-08-17 | 62 | 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