Atlas FDA

KNC

26 FDA 510(k) clearances · Product code

56 daysmedian time to decision
428 days90th percentile
26clearances measured

FDA profile

Official device name
Table, Obstetric (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4900
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2021: 25 · 2022: 25 · 2023: 45 · 2024: 71 · 2025: 114 · 2026: 91
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
L720 EXAMINATION CHAIR (K001261)Luneau Gynecologie SA2000-06-08
NON-LINTING DELIVERY BLANKET (K932035)Amsco Sterile Recoveries, Inc.1994-05-26
MEDICAL DISPOSABLE BEDDING (K924420)Hill-Rom, Inc.1993-12-10
BD6000 THE OPTIMA & BD5000 BIRTHING BED (K914544)Lic Care, Inc.1993-11-24
AFFINITY BED MODEL 3600 SERIES (K915779)Hill-Rom, Inc.1993-02-24
GARDOSI BIRTHING CUSHION (K903973)Graphic Controls Corp.1990-09-27
OBSTETRICAL SAFETY SYSTEM (K884868)Buckman Co., Inc.1989-03-01
STRYKER MODEL 977 BIRTHING BED (K870745)Stryker Corp.1987-02-27
PALMER OBSTETRIC BRACE (K864194)Ad-Tech Medical Instrument Corp1987-01-14
MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 (K862931)Global Medical Prods, Inc.1986-08-07
LABOR-DELIVERY STRETCH/BED (K861030)Adel Medical , Ltd.1986-04-23
MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 (K852174)Daun International, Inc.1985-09-06
CAT. NO. S-5300-E BIRTHING BED (K852171)Shampaine/Wilson1985-08-30
PALMER OBSTETIC BRACE (K844183)Mic Medical Corp.1985-02-04
LORRAINE DSL LABOR & DELIVERY BED (K842962)Pulley-Kellam Co., Inc.1984-09-25
LABOR/DELIVERY/RECOVERY BED LDR-600 (K833321)Adel Medical , Ltd.1983-11-14
BIRTHWELL BIRTHING SYSTEM (K831998)Qulab Co.1983-09-12
DELIVERY 4 TABLE (K831309)Amsco Co.1983-06-15
S & W MODEL ASO (K830873)S & W Enterprises, Inc.1983-05-13
O.N.A.T. (K820175)Latex Medical Devices, Inc.1982-01-29
CENTURY BIRTHING CHAIR (K811902)Century Manufacturing Co.1981-08-25
LIC OBSTETRICAL TABLE (K812141)Lada Intl., Inc.1981-08-25
ADEL MEDICAL BIRTHING BED, MOD. LD-400 (K801622)Adel Medical , Ltd.1980-08-14
OBSTETRICAL BEDS (K792568)Ets Rene Marzet1980-01-28
S/A 7800 BIRTH SUPPORT CHAIR (K790950)Schlosser Alberti Co.1979-08-03
TABLE, EXAMINATION (K770437)I E Industries1977-03-23

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Every clearance here is in the API, with alerts when new ones post.