Atlas FDA

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

Safety Syringes, Inc. · Predicate Candidate Screening

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

87 daysmedian FDA review time
206 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K123743ULTRASAFE PLUS PASSIVE NEEDLE GUARDSafety Syringes, Inc.2013-03-261100
K122558ULTRASAFE PASSIVE NEEDLE GUARDSafety Syringes, Inc.2012-09-20290
K060743MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SSafety Syringes, Inc.2006-04-28390
K042712TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEMSafety Syringes, Inc.2004-10-15150
K013801ULTRASAFE DENTAL INJECTION SYSTEMSafety Syringes, Inc.2001-12-13281
K011369ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACSafety Syringes, Inc.2001-05-29250
K972900ULTRASAFE MODEL T200 INJECTORSafety Syringes, Inc.1998-02-262040
K972877ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GSafety Syringes, Inc.1998-02-262060
K972878ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B1Safety Syringes, Inc.1997-10-30870
K944425ULTRASAFE ASPIRATING SYRINGESafety Syringes, Inc.1995-01-261360

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