510(k) evidence is generally inadmissible because the 510(k) clearance process solely determines substantial equivalency, and not safety and efficacy. However, in a products liability claim premised not only on principles of negligence, but particularly on the reasonableness of a manufacturer’s conduct in not performing clinical trials or studies, evidence of 510(k) clearance has significant probative value under N.J.R.E. 401 that is not substantially outweighed by the risk of prejudice and potential juror confusion under N.J.R.E. 403. Therefore, under the specific facts and circumstances of this case, the Court affirms the judgment of the Appellate Division. However, the Court parts ways with the Appellate Division’s decision as to its suggestion that the scope and admissibility of 510(k) evidence should be determined in a Rule 104 hearing. Instead, the scope and admissibility of 510(k) evidence should be resolved at the hearing on a motion in limine, which is how the issue was and, presumably, will be raised. Section 5 of the PLA does not bar plaintiffs’ recovery of punitive damages, and because evidence of 510(k) clearance should have been admitted in the first stage of trial as relevant to the reasonableness of Bard’s conduct in not performing clinical trials or studies, it would also be admissible in the second, punitive damages stage.