Cleared Traditional

K812722 - SAFE GUARD

K812722 is an FDA 510(k) clearance for SAFE GUARD, manufactured by Concept, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K812722 · Concept, Inc. · General & Plastic Surgery device
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Nov 1981
Decision
38d
Days
Class 2
Risk

K812722 is an FDA 510(k) clearance for the SAFE GUARD. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1981 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Concept, Inc. devices

FDA 510(k) Submission Details - K812722

510(k) Number K812722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1981
Decision Date November 05, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1210
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K812722.
SYBRON BOVIE CSV HAND CONTR. ELECTROSURG
K820494 · Sybron Corp. · Apr 1982
E2508 DISPOSABLE HANDSWITCHING PENCIL
K813071 · Valleylab, Inc. · Nov 1981
E2502 & E2502B LECTROSWITCH
K813072 · Valleylab, Inc. · Nov 1981
PREGELLED DISPOS. ELECTROSURG. GROUND EL
K810277 · Conmedcorp · Mar 1981
DAVOL ELECTRO MEDICAL SYSTEMS
K810273 · C.R. Bard, Inc. · Mar 1981
ELECTROSURGICAL TIP CLEANER & HOLDER
K803055 · Devon Industries, Inc. · Feb 1981