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

Neuromed, Inc. — Predicate Candidate Screening

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

92 daysmedian FDA review time

679 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K960728	ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)	Neuromed, Inc.	1996-05-22	90
K930536	NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC	Neuromed, Inc.	1994-12-15	687
K930498	NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN	Neuromed, Inc.	1994-12-12	679
K930242	INTRODE INT-8	Neuromed, Inc.	1994-02-02	379
K921319	NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30	Neuromed, Inc.	1993-05-05	412
K905596	NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST	Neuromed, Inc.	1991-03-11	88
K905255	NEUROMED MODEL 1992 LS LAMITRODE LEAD	Neuromed, Inc.	1991-01-25	65
K903814	NEUROMED TS8 TEST STIMULATOR	Neuromed, Inc.	1991-01-16	149
K901499	NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.	Neuromed, Inc.	1990-06-29	92
K862915	MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL)	Neuromed, Inc.	1986-10-06	66
K860185	UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER	Neuromed, Inc.	1986-04-04	73
K860158	8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR	Neuromed, Inc.	1986-03-07	50
K853643	MULTISTIM LAMINECTOMY ELECTRODE	Neuromed, Inc.	1985-11-14	72
K852326	UNISTIM UNT-1	Neuromed, Inc.	1985-11-14	168
K852920	QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF	Neuromed, Inc.	1985-10-10	92

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