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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Internacional Farmacéutica S.A DE C.V · Predicate Candidate Screening

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

77 daysmedian FDA review time
231 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (CalypsInternacional Farmacéutica S.A DE C.V2025-10-03290
K072859ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURESInternacional Farmaceutica, S.A. DE C.V.2008-05-232310
K072863ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICInternacional Farmaceutica, S.A. DE C.V.2008-05-232310
K041048POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTUREInternacional Farmaceutica, S.A. DE C.V.2004-06-04430
K040282ATRAMAT AND SORB-FAST POLYGLYCOLIC ACIDInternacional Farmaceutica, S.A. DE C.V.2004-04-29830
K913185STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUTInternacional Farmaceutica, S.A. DE C.V.1991-12-041390
K911354STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURESInternacional Farmaceutica, S.A. DE C.V.1991-10-252130
K911189STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTUREInternacional Farmaceutica, S.A. DE C.V.1991-04-25380
K905285IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURESInternacional Farmaceutica, S.A. DE C.V.1991-02-11770
K905286IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURESInternacional Farmaceutica, S.A. DE C.V.1991-02-11770
K905287IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURESInternacional Farmaceutica, S.A. DE C.V.1991-02-11770

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