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

Zmi Corp. — Predicate Candidate Screening

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

105 daysmedian FDA review time

307 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K915100	BRINDLEY & SMITH ET-1000	Zmi Corp.	1992-09-14	307	0
K915159	PEDIATRIC MULTI-FUNCTION ELECTRODES	Zmi Corp.	1992-02-07	85	1
K913484	ZOLL D-900 DEFIBRILLATOR	Zmi Corp.	1991-12-16	132	0
K911956	ZOLL PD-1400 PACER/DEFIBRILLATOR	Zmi Corp.	1991-07-31	90	0
K895032	ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES	Zmi Corp.	1989-10-12	65	0
K885166	ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES	Zmi Corp.	1989-05-01	139	0
K873402	ZOLL NTP-1200 PACER/DEFIBRILLATOR	Zmi Corp.	1987-11-23	91	0
K855015	NONINVASIVE TEMP. PACEMAKER NTP-1000	Zmi Corp.	1986-03-31	105	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