Atlas FDA

GENERAL SURGERY TRAY

FDA 510(k) clearance K842648 · decided 1984-09-20

Clearance details

K-number
K842648
Device name
GENERAL SURGERY TRAY
Applicant
Deroyal Industries, Inc.
Decision
Substantially Equivalent
Date received
1984-08-13
Decision date
1984-09-20
Days to decision
38 days
Clearance type
Traditional
Product code
LRO
Device class
2
Regulation number
878.4370
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Powell, TN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Deroyal Industries

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Medline General Surgery Tray (K213481)Medline Industries, Inc.2022-05-24
Medline Cardiovascular Procedure Kit (K212258)Medline Industries, Inc.2021-12-03
SURGICAL DRAPE KIT - D.I.R.R.A. SRL (K041080)D.I.R.R.A. S.R.L.2004-11-30
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (K030721)Ballard Medical Products2003-03-31
AMSINO TRACHEOSTOMY CARE TRAY (K023276)Amsino International, Inc.2002-12-09
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (K980137)Worldwide Medical Technologies, LLC1998-01-30
OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (K971061)Opportunity, Inc.1997-06-11
OPPORTUNITY INC. GENERAL PURPOSE TRAY (K971062)Opportunity, Inc.1997-06-09
NEUROLOGICAL OR CRANI TRAYS (PACKS) (K932221)Associated Medical Products Co.1997-03-19
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (K970286)Medline Industries, Inc.1997-03-10
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (K965201)Trinity Laboratories, Inc.1997-02-14
RUNYON LARGE VOLUME PARACENTESIS KIT (K970187)Gi Supply1997-02-14

Recalls involving this device

RecordFirmDate
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 recall (Z-0307-2025)DeRoyal Industries Inc2024-11-05
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 recall (Z-0308-2025)DeRoyal Industries Inc2024-11-05
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 recall (Z-0622-2024)DeRoyal Industries Inc2024-09-30
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 recall (Z-1382-2024)DeRoyal Industries Inc2024-03-29
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit recall (Z-0116-2024)DeRoyal Industries Inc2023-10-16
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDI recall (Z-2086-2023)DeRoyal Industries Inc2023-07-03
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jacks recall (Z-1691-2023)DeRoyal Industries Inc2023-06-07
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 recall (Z-0927-2023)DeRoyal Industries Inc2023-01-09
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set recall (Z-2499-2021)Deroyal Industries, Inc. Lafollette2021-09-29
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 recall (Z-1832-2021)DeRoyal Industries Inc2021-06-10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpa recall (Z-1410-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chron recall (Z-1411-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoul recall (Z-1412-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC G recall (Z-1413-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cysto recall (Z-1414-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC L recall (Z-1415-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC T recall (Z-1416-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophth recall (Z-1417-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik recall (Z-1418-2020)Deroyal Industries, Inc. Lafollette2020-02-19
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC O recall (Z-1419-2020)Deroyal Industries, Inc. Lafollette2020-02-19
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit. recall (Z-2678-2016)DeRoyal Industries Inc2016-08-26
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O, recall (Z-2679-2016)DeRoyal Industries Inc2016-08-26