Atlas FDA

FNJ

39 FDA 510(k) clearances · Product code

37 daysmedian time to decision
123 days90th percentile
39clearances measured

FDA profile

Official device name
Bed, Manual
Device class
Class I (low risk)
Regulation
21 CFR 880.5120
Medical specialty
General Hospital
Flags
GMP exempt
Adverse events (MAUDE)
2015: 9 · 2022: 23 · 2023: 60 · 2024: 44 · 2025: 61 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
KING KRIB (K934298)Noritage, Inc.1994-01-26
CRADLE, HOSPITAL BED CLOTHING (K892877)Warsaw Orthopedic, Inc.1989-06-15
BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT (K885241)King Mfg. Co.1989-02-24
SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED (K884542)Commercial Products & Engineering Co.1988-11-21
ENVIROTENT (BED) (K881725)Envirotents, Inc.1988-11-08
MSI STANDARD BED MODELS: L1097-64 AND L1085-64 (K881961)Med Service, Inc.1988-11-01
MSI 3003 SERIES BED (K881964)Med Service, Inc.1988-06-28
MSI 2005 SERIES BED (K881962)Med Service, Inc.1988-06-03
FOLDING HOSPITAL COT NSN 6530-00-299-8517 (K881043)Junkin Safety Appliance Co., Inc.1988-04-12
PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG (K870166)George C. Kuhn1987-03-13
VSID MEDICAL THREE-FOLDING BED (K870310)China National Medicines & Health Prod. I/E Corp.1987-02-10
PENOX HOSPITAL BED (K864667)Penox Technologies, Inc.1987-01-21
ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPE (K863688)Brenner Metal Prod Corp.1987-01-20
COT, FOLDING, HOSPITAL, ALUMINUM (K863691)Brenner Metal Prod Corp.1987-01-20
BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS (K863694)Brenner Metal Prod Corp.1987-01-20
CART, ORTHOPEDIC BED, STRYKER (K863685)Brenner Metal Prod Corp.1987-01-15
ICU/CPU TRANSPORT TRAY (K864878)Orthopedic Systems, Inc.1987-01-06
NESBIT EVANS NURSING HOME BED (K864203)J. Nesbit Evans & Co.1986-11-07
HOSPITAL BED (K863748)Global Medical Prods, Inc.1986-10-09
COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED (K861678)Sierra Corp.1986-05-08
TIPS AND PADS, CANE,CRUTCH AND WALKER (K854940)Healthtech Industries, Inc.1986-01-30
EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 (K854776)Carrom Healthcare, Inc.1985-12-13
COMBO 36 (K854257)Kg Engineering, Inc.1985-11-18
AM FAB SIDE RAILS MODEL 5000 (K852890)Am Fab, Inc.1985-07-24
MERIVAARA HOSPITAL BED (K851552)Daun International, Inc.1985-05-08
BERNIER ARM SUPPORT (K840653)T.C. Toll Corp.1984-03-19
EGERTON TURNING & TILTING NET SUSPEN BED (K832845)Kinetic Concepts, Inc.1983-11-28
SIDE RAIL PADS (K823821)Danek Medical, Inc.1983-01-21
DEVICE FOR REPOSITIONING A BET PATIENT (K813356)Ali-Oop Co., Inc.1982-02-10
GER 540, GER 541 MANUAL BED (K812600)G.W. Healthcare, Inc.1981-09-23
SWEEN UNIVERSAL BED RAIL PADS (K810846)Sween Corp.1981-04-17
BED ROCKING DEVICE (K801517)Wesler1980-10-10
THE VERSA-BED (K792298)First & Ten, Inc.1979-12-20
SKIL-CARE BED RAIL PADS (K791993)Skil-Care Corp.1979-10-26
ECHO CARDIOGRAM PAD (K791189)Alimed, Inc.1979-07-17
TRAPEZE FLOOR BASE (K772261)Med Fusion Systems, Inc.1978-01-26
TRAPEZE BAR KNOCKED DOWN (K772262)Med Fusion Systems, Inc.1978-01-26
TELESCOPING BEDRAILS (K772260)Med Fusion Systems, Inc.1978-01-26
PAD, POLYETHER FOAM, OPEN CELL (K760315)Gaymar Industries, Inc.1976-08-11

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