Cleared Traditional

K960738 - STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)

K960738 is an FDA 510(k) clearance for STERITITE SEALED CONTAINER(SC08F, manufactured by Engineered Custom Mfg., Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 438-day FDA review.

K960738 · Engineered Custom Mfg., Inc. · General Hospital
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May 1997
Decision
438d
Days
Class 2
Risk

K960738 is an FDA 510(k) clearance for the STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC.... Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Engineered Custom Mfg., Inc. (Ridgefield, US). The FDA issued a Cleared decision on May 6, 1997 after a review of 438 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Engineered Custom Mfg., Inc. devices

FDA 510(k) Submission Details - K960738

510(k) Number K960738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1996
Decision Date May 06, 1997
Days to Decision 438 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 129d · This submission: 438d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K960738.
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
K973827 · Kimberly-Clark Corp. · Feb 1998
SAFEPASS STERILIZATION POUCH
K973981 · Adroit Medical Systems, Inc. · Jan 1998
REXAM FRACTURE RESISTANT POUCH
K973440 · Rexam Medical Packaging, Inc. · Oct 1997
DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE
K962545 · Sterilization Cassette Systems, Inc. · Mar 1997
REXAM SELF-SEAL TYVEK POUCH
K962600 · Rexam Medical Packaging, Inc. · Aug 1996
OXBORO-MEDICAL FOAM INSTRUMENT HOLDER
K953068 · Oxboro Medical Intl., Inc. · Jan 1996