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Instrusafe In-2648

by Summit Medical, LLC

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Nov 2026

Documents

Trust

Unverified

Source GUDID, synced 10 Nov 2026.

Regulatory status

as of registry sync 10 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385640032728 UDI-DI Date1 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151166 Date18 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151166 decided 18 Aug 2015 Active· +7 more in the status table
  • FDA GUDID UDI-DI 00385640032728 listed 1 Dec 2017 Listed

Timeline

9 dated events

  1. Cleared FDA 510(k) K051157
  2. Cleared FDA 510(k) K133015
  3. Cleared FDA 510(k) K140289
  4. Cleared FDA 510(k) K141513
  5. Cleared FDA 510(k) K142630
  6. Cleared FDA 510(k) K142768
  7. Cleared FDA 510(k) K150540
  8. Cleared FDA 510(k) K151166
  9. Listed FDA GUDID 00385640032728

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Instrusafe
Generic name
Instrument tray, reusable
Model / reference
IN-2648
Primary DI / UDI-DI
00385640032728
510(k) Number
FDA product code
KCT
GMDN term
Instrument tray, reusable
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Overview

AI-generated summary, 10 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Instrusafe IN-2648 is a reusable instrument tray. The FDA lists it under the product name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories.

This device received 510(k) clearance under K051157, K133015, K140289, K141513, K142630, K142768, K150540, and K151166. It is classified as FDA Class II under regulation number 880.6850 with product code KCT.

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K051157)

and 8 more cleared under K051157

Cleared under the same submission (K133015)

and 8 more cleared under K133015

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Questions

AI-generated answers, 10 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Instrusafe IN-2648?

    It is recorded under the GMDN device type "Instrument tray, reusable", which GMDN defines as "A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures". FDA lists it under the product name "Sterilization Wrap Containers, Trays, Cassettes & Other Accessories". It is recorded as Class II.

  • What are the product code and regulation of the Instrusafe IN-2648?

    FDA records the Instrusafe IN-2648 under product code KCT and regulation number 880.6850.

  • Who makes the Instrusafe IN-2648?

    Summit Medical, LLC is the manufacturer on record for the Instrusafe IN-2648.

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)