Skip to content

Deterioration Index Version 2

by Epic Systems Corporation

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 9 Nov 2026

Documents

510(k) K260008

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850053416019 UDI-DI Date26 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK260008 Date18 Sep 2026DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Clinical decision management support software
Model / reference
2
Primary DI / UDI-DI
00850053416019
510(k) Number
FDA product code
QNL
GMDN term
Clinical decision management support software
Device class
Class II
Regulation number
870.2210
GUDID distribution status
In Commercial Distribution

Other devices from Epic Systems Corporation

See all devices from Epic Systems Corporation →

Properties

Other properties (15)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No