FDA WARNING_LETTER - Impact Instrumentation, Inc. - March 08, 2010

An FDA inspection of Impact Instrumentation, Inc. from February 17 to March 8, 2010, revealed significant violations. The firm manufactures medical devices, including Uni-Vent 731 Series Model EMV+, Uni-Vent 731 Series Model EMV, Uni-Vent Eagle Portable Ventilator, and Special Medical Emergency Evacuation Device (SMEED).

The Uni-Vent 731 Series Model EMV+ (800-EMVP-01) was offered for sale without required marketing approval or clearance, making it adulterated under 21 U.S.C. 351(f)(1)(B) and misbranded under 21 U.S.C. 352(o). This model included significant changes (e.g., "Pleth" waveform, new ventilation modes, apnea alarm) from the previously cleared Uni-Vent 731 Series Model EMV+ (800-EMVP-00) (K091238), requiring a new 510(k) submission per 21 C.F.R. 807.81(a)(3). Labeling changes also necessitated a new 510(k).

Additionally, all listed devices were adulterated under 21 U.S.C. 351(h) due to non-conformity with