Cleared Traditional

K810654 - STOPPERLESS HOT/COLD RUBBER WATER BOTTLE

K810654 is the FDA 510(k) clearance for STOPPERLESS HOT/COLD RUBBER WATER BOTTLE by First Industries, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDF) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K810654 · First Industries, Inc. · Gastroenterology & Urology device
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Mar 1981
Decision
17d
Days
Class 2
Risk

K810654 is an FDA 510(k) clearance for the STOPPERLESS HOT/COLD RUBBER WATER BOTTLE. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by First Industries, Inc. (Walker, US). The FDA issued a Cleared decision on March 27, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 First Industries, Inc. devices

Submission Details

510(k) Number K810654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1981
Decision Date March 27, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDF Colonoscope And Accessories, Flexible/rigid

All 59
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K810654.
PENTAX FC-38LA & FC-38SA COLONOFIBER
K822846 · Pentax Precision Instrument Corp. · Oct 1982
PENTAX COLONOSCOPE MODEL FC-34LA
K810682 · Pentax Precision Instrument Corp. · Apr 1981
PENTAX COLONOSCOPE MODEL FC-34 MA
K810791 · Pentax Precision Instrument Corp. · Mar 1981
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
K801223 · Pentax Precision Instrument Corp. · Jun 1980