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

Medspec Corp. — Predicate Candidate Screening

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

36 daysmedian FDA review time

87 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K813012	STERILE BASIN SETS	Medspec Corp.	1981-11-06	10
K812711	STERILE GAUZE PADS 12PLY	Medspec Corp.	1981-11-02	39
K812710	STERILE LAPAROTOMY SPONGES-X-RAY DETECT	Medspec Corp.	1981-11-02	39
K812707	STERILE DISSECTOR SPONGES-X-RAY DETECT	Medspec Corp.	1981-11-02	39
K812709	STERILE DENTAL ROLL	Medspec Corp.	1981-10-23	29
K810071	STERILE SILICONE TUBING	Medspec Corp.	1981-02-12	30
K810069	STERILE AIRWAY	Medspec Corp.	1981-02-02	20
K802060	STERILE TONSIL SPONGES	Medspec Corp.	1980-10-10	46
K801069	STERILE ISOLATION GOWN	Medspec Corp.	1980-05-20	14
K801068	STERILE ABDOMINAL PAD	Medspec Corp.	1980-05-20	14
K800279	MEDSPEC RUBBER BANDS	Medspec Corp.	1980-05-02	87
K800278	MEDSPEC SAFETY PINS	Medspec Corp.	1980-05-02	87
K800280	MEDSPEC RUBBER ELASTIC BANDAGES	Medspec Corp.	1980-03-12	36
K800277	MEDSPEC RAYON BALLS	Medspec Corp.	1980-03-12	36
K800281	MEDSPEC PACKING GAUZE	Medspec Corp.	1980-03-12	36

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