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

Medi-Spec — Predicate Candidate Screening

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

44 daysmedian FDA review time

149 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K833068	LAMINARIA JAPONICA CERVICAL DILATOR	Medi-Spec	1984-02-04	149
K812694	WHISK-R	Medi-Spec	1981-10-26	34
K812426	UTERINE ASPIRATION CURETTES(RIGID&FLEX)	Medi-Spec	1981-10-08	44
K801554	STERILE CAST PADDING	Medi-Spec	1980-08-04	27
K800404	MEDSPEC OPERATIVE OPTHALMIC KIT	Medi-Spec	1980-04-24	58
K800490	STERILE DRESSING PACK	Medi-Spec	1980-03-12	8
K790952	CLAMP COVERS	Medi-Spec	1979-06-05	14
K780548	DISPOSA-LOOPS	Medi-Spec	1978-08-21	138

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