Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Pace Medical — Predicate Candidate Screening

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

75 daysmedian FDA review time

190 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K011980	ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 48	Pace Medical	2001-09-12	79
K012392	DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 42	Pace Medical	2001-09-04	39
K002204	PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 52	Pace Medical	2000-10-18	90
K002497	MODEL 4810 ANALYZER OUTPUT ADAPTER	Pace Medical	2000-10-10	57
K002496	MODEL 4815 ADAPTER	Pace Medical	2000-10-10	57
K001180	TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 523	Pace Medical	2000-06-27	77
K925143	MODEL 4800 ACCUPACE PACING SYSTEM ANALYER	Pace Medical	1994-09-27	714
K931662	LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES	Pace Medical	1993-08-31	148
K922899	MODEL 4280 SURGICAL EXTENSION CABLE	Pace Medical	1992-12-23	190
K913805	MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER	Pace Medical	1991-11-19	85
K913134	MODEL 4220	Pace Medical	1991-08-22	37
K912545	MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE	Pace Medical	1991-07-26	46
K902679	MODELS 4201, 4231 & 4235 EXTENSION CABLES	Pace Medical	1990-07-19	30
K896352	MODEL EC4542G MINIATURE	Pace Medical	1990-01-24	79
K890988	MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE	Pace Medical	1989-08-25	179
K874743	PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390	Pace Medical	1988-01-19	62
K871915	MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543	Pace Medical	1987-06-10	23
K870323	MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER	Pace Medical	1987-03-03	34
K864153	PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290	Pace Medical	1987-01-06	75

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