Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Telectronics, Inc. — Predicate Candidate Screening

107 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

47 daysmedian FDA review time

149 days90th percentile

107clearances measured

K-number	Device	Applicant	Decided	Review days
K890895	IMPLANTABLE ADAPTOR 033-380	Telectronics, Inc.	1990-03-06	377
K891231	OPTIMA MPT AND SPT PACEMAKERS	Telectronics, Inc.	1989-09-12	189
K890350	VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)	Telectronics, Inc.	1989-02-02	86
K884411	OPTIMA MPT AND SPT PACEMAKERS	Telectronics, Inc.	1989-01-26	98
K884278	IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436	Telectronics, Inc.	1988-12-15	64
K881837	OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D	Telectronics, Inc.	1988-07-18	77
K874664	IMPLANTABLE ELECTRODE LEAD, MODEL 030-446	Telectronics, Inc.	1988-05-31	200
K864712	MODEL 1740 PERSONAL POCKET PROGRAMMER	Telectronics, Inc.	1987-12-17	379
K872766	IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS	Telectronics, Inc.	1987-11-04	113
K865098	SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438	Telectronics, Inc.	1987-08-18	231
K871992	IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS	Telectronics, Inc.	1987-08-12	78
K871986	MODEL 5600B PROGRAMMER, PACEMAKER	Telectronics, Inc.	1987-06-24	33
K871861	IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS	Telectronics, Inc.	1987-06-05	23
K864618	IMPLANTABLE ELECTRODE LEAD, MODEL 030-439	Telectronics, Inc.	1987-05-21	178
K870610	RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE	Telectronics, Inc.	1987-03-20	46
K861767	IMPLANTABLE ELECTRODE LEAD, MODEL 030-436	Telectronics, Inc.	1986-07-18	72
K860573	IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR	Telectronics, Inc.	1986-05-28	103
K854997	IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY	Telectronics, Inc.	1986-02-12	62
K854560	IMPLANTABLE PROGRAMMABLE PULSE GENERATOR	Telectronics, Inc.	1986-01-16	63
K854142	STYLET INTRODUCER FUNNEL	Telectronics, Inc.	1986-01-15	96
K852710	IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A	Telectronics, Inc.	1985-12-04	161
K854143	BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS	Telectronics, Inc.	1985-11-01	21
K852708	IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A	Telectronics, Inc.	1985-10-01	97
K852709	IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A	Telectronics, Inc.	1985-09-17	83
K853221	SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401	Telectronics, Inc.	1985-09-17	47
K853222	SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402	Telectronics, Inc.	1985-09-17	47
K853223	SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407	Telectronics, Inc.	1985-09-17	47
K852972	IMPLANTABLE ELECTRODE LEAD, MODEL 030-400	Telectronics, Inc.	1985-09-16	63
K853206	IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW	Telectronics, Inc.	1985-09-12	43
K852915	SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281	Telectronics, Inc.	1985-07-29	35
K852917	SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283	Telectronics, Inc.	1985-07-29	35
K852918	SLIM ART J. BIP PACING LEAD USING POLY #030-2821	Telectronics, Inc.	1985-07-29	35
K852916	SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284	Telectronics, Inc.	1985-07-29	35
K851461	IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE	Telectronics, Inc.	1985-07-11	91
K851460	NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA	Telectronics, Inc.	1985-05-10	29
K851296	IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH	Telectronics, Inc.	1985-04-11	10
K851297	IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET	Telectronics, Inc.	1985-04-10	9
K851295	IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH	Telectronics, Inc.	1985-04-10	9
K851294	IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH	Telectronics, Inc.	1985-04-10	9
K851081	IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II	Telectronics, Inc.	1985-04-04	17
K850252	QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR	Telectronics, Inc.	1985-04-04	72
K842473	IMPLANTABLE PROGRAMMABLE PULSE GENERAT	Telectronics, Inc.	1984-10-26	123
K840026	IMPLANTABLE ELECTRODE UNIPOLAR ADAPT	Telectronics, Inc.	1984-05-23	139
K840025	IMPLANTABLE ELECTRODE BIPOLAR ADAPT	Telectronics, Inc.	1984-05-23	139
K840737	IMPLANTABLE PROGRAMMABLE PULSE GENER	Telectronics, Inc.	1984-05-16	85
K840701	PACEMAKER 147 VVI-THE OPTINIA	Telectronics, Inc.	1984-05-02	75
K833428	IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN	Telectronics, Inc.	1984-02-10	129
K833427	IMPLANTABLE BIPOLAR CARDIAC PULSE GEN	Telectronics, Inc.	1984-02-10	129
K834533	ELECTRODE LEAD CONSTRUCTION	Telectronics, Inc.	1984-01-30	39
K833798	OPTIMA MDT PULSE GENERATOR W/TELEMETRY	Telectronics, Inc.	1983-12-01	31

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